FDA Adverse Event Malfunction Summary report: N

COBAS INTEGRA 400 PLUS

MDR report key: 1061925 · Received June 16, 2008

Report

Report Number
1823260-2008-04739
Event Type
Malfunction
Date Received
June 16, 2008
Date of Event
February 6, 2008
Report Date
June 13, 2008
Manufacturer
ROCHE DIAGNOSTICS
Product Code
JJE
PMA / PMN Number
K951595
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
MA, US
Reporter Occupation
MEDICAL TECHNOLOGIST

Narratives

Description of Event or Problem · 1

SEVEN PATIENT SAMPLES WITH DISCREPANT GLUCOSE RESULTS. PATIENTS 1 THROUGH 6 WERE REPEATED TWICE, IN 2008 AND ABOUT 15 DAYS LATER, EXCEPT PATIENT 2 WHO WAS REPEATED ONCE ON THE INITIAL DATE. AT ABOUT 2 MONTHS PRIOR: PATIENT 1, INITIAL GAVE 39 MG/DL, REPEATS GAVE 79 AND 92 MG/DL. ABOUT 9 DAYS LATER: PATIENT 2, INITIAL GAVE 48 MG/DL, REPEAT GAVE 56 MG/DL. A SECOND SAMPLE RESULTED AT 75 MG/DL BY DIFFERENT ANALYZER. AT ABOUT APPROX 2 WEEKS LATER: PATIENT 3, INITIAL GAVE 42 MG/DL, REPEATS GAVE 79 AND 88 MG/DL. A SECOND SAMPLE RESULTED AT 85 MG/DL BY DIFFERENT ANALYZER. AT ABOUT 15 DAYS LATER: PATIENT 4, INITIAL GAVE 41 MG/DL. REPEATS GAVE 78 MG/DL EACH TIME. PATIENT 5, INITIAL GAVE 48 MG/DL; REPEATS GAVE 99 AND 88 MG/DL. A SECOND SAMPLE RESULTED AT 89 MG/DL BY A DIFFERENT ANALYZER. PATIENT 6, INITIAL GAVE 49 MG/DL; REPEATS GAVE 72 AND 63 MG/DL. A SECOND SAMPLE RESULTED AT 76 MG/DL BY DIFFERENT ANALYZER. AT ABOUT 47 DAYS LATER: PATIENT 7, INITIAL GAVE 46 MG/DL, REPEAT SAME DAY GAVE 65 MG/DL. A SECOND SAMPLE GAVE 74 MG/DL. INITIAL RESULTS WERE REPORTED. PATIENTS NOT ADVERSELY AFFECTED. ALTHOUGH A ROOT CAUSE WAS NOT DETERMINED, THE FIELD SERVICE REPRESENTATIVE LUBRICATED ALL MECHANISMS AND REQUIRED SURFACES, AND REBUILT DOSAGE PIPETTORS. PERFORMANCE TESTS WAS PERFORMED AND WITHIN.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 COBAS INTEGRA 400 PLUS CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS I400+

Patients

Seq Age Sex Outcome Treatment
1 UNK