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Adverse Event Report

BECKMAN INSTRUMENTS, INC. HYBRITECH ICON II HCG HCG IMMUNOCONCENTRATION TEST KIT   back to search results
Model Number ICON II HCG
Event Date 12/19/1997
Event Type  Other   Patient Outcome  Other;
Event Description

Customer reported that a pt presented at the user facility on 12/19/1997 with abdominal pains. An icon hcg test for pregnancy was performed on the pts serum with negative results. All controls performed as expected. The pt was then given x-rays of the chest, kidneys, ureter and bladder. The x-rays did not identify a cause of the abdominal pain. On 1/3/98 the pt was given an ultrasound and a fetus of approx 5 weeks was identified. No pt sample was available for further testing. Pt indicated that her last menses was 11/28/97. The icon hcg kit instructions indicate that the sensitivity for serum sample is 10mlu/ml and in most cases elevated hcg will be detected in the first week after implantation or 4-5 days before a missed menses. Estimated missed menses for this pt would be approx 12/27/97. Based on currently available info, it appears that the hcg levels may have been below 10 mlu/ml on 12/19/97. If this is the case, then icon hcg test kit performed according to labeled claims. Labeling also states that when a negative result is obtained and pregnancy is suspected, a second icno hcg test should be performed on a new sample 48 hours or more after the initial test.

 
Manufacturer Narrative

H3. No pt sample or device was returned to the mfr for evaluation or re-testing. Device used expired on 1/14/98.

 
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Brand NameHYBRITECH ICON II HCG
Type of DeviceHCG IMMUNOCONCENTRATION TEST KIT
Baseline Brand NameHYBRITECH ICON II HCG
Baseline Generic NameHCG IMMUNOCONCENTRATION TEST KIT
Baseline Catalogue Number004135
Baseline Model NumberICON II HCG
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
BECKMAN INSTRUMENTS, INC.
8958 terman ct.
san diego CA 92196
Manufacturer (Section D)
BECKMAN INSTRUMENTS, INC.
8958 terman ct.
san diego CA 92196
Manufacturer (Section G)
BECKMAN COULTER, INC.
8958 terman ct.
san diego CA 92121
Device Event Key145887
MDR Report Key149714
Event Key140555
Report Number2022635-1998-00001
Device Sequence Number1
Product CodeJHI
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Other
Type of Report Initial
Report Date 02/11/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/13/1998
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date01/14/1998
Device MODEL NumberICON II HCG
Device Catalogue Number004135
Device LOT Number790186
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/28/1998
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided
Type of Device Usage Initial

Database last updated on January 30, 2009

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