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Adverse Event Report

BECKMAN COULTER, INC. SYNCHRON CX7 CLINICAL CHEMISTRY ANALYZER   back to search results
Model Number SYNCHRON CX7 - PHENYTOIN
Event Date 02/23/2000
Event Type  Malfunction   Patient Outcome  Other;
Event Description

Customer states that a falsely elevated results, above the therapeutic range, was obtained for phenytoin on the synchron cx7 system. The result exceeded the physician's expectations for this pt. Different methodologies were used on the same pt sample and the phenytoin result was within the therapeutic range.

 
Manufacturer Narrative

H3. Field service evaluated the system at the user facility. Recommended user submit pt sample for mfr investigation. Current info suggests unknown interferent in pt sample affected system performance. H6. Conclusions: the unidentified interferent, if any, in the pt sample may be unknown to the user.

 
Manufacturer Narrative

H3: field service evaluated the system at the user facility. Recommended user submit pt sample for manufacturer investigation. Current information suggests unknown interferent in pt sample affected system performance. H6: conclusions: the unidentified interferent, if any, in the pt sample may be unknown to the user.

 
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Brand NameSYNCHRON CX7
Type of DeviceCLINICAL CHEMISTRY ANALYZER
Baseline Brand NameSYNCHRON CX7
Baseline Generic NameCLINICAL CHEMISTRY ANALYZER
Baseline Catalogue Number756601
Baseline Model NumberSYNCHRON CX7 - PHENYTOIN
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
BECKMAN COULTER, INC.
250 s. kraemer bl.
brea CA 92822
Manufacturer (Section D)
BECKMAN COULTER, INC.
250 s. kraemer bl.
brea CA 92822
Manufacturer Contact
regina o'meara
200 s. kraemer blvd
p.o. box 8000, mail stop w-561
brea , CA 92822-8000
(714) 961 -4489
Device Event Key264012
MDR Report Key272708
Event Key255705
Report Number2050012-2000-00001
Device Sequence Number1
Product CodeJJC
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Medical Technologist
Type of Report Initial,Followup
Report Date 03/25/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/31/2000
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberSYNCHRON CX7 - PHENYTOIN
Device Catalogue Number756601
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/23/2000
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided
Type of Device Usage Reuse

Database last updated on January 30, 2009

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