FDA Adverse Event Malfunction Summary report: N

ANALYTICAL D MODULE

MDR report key: 1193388 · Received October 7, 2008

Report

Report Number
1823260-2008-07408
Event Type
Malfunction
Date Received
October 7, 2008
Date of Event
September 15, 2008
Report Date
October 7, 2008
Manufacturer
ROCHE DIAGNOSTICS
Product Code
JJE
PMA / PMN Number
K953239
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
CT, US
Reporter Occupation
MEDICAL TECHNOLOGIST

Narratives

Description of Event or Problem · 1

USER RECEIVED HIGH RESULTS FOR BUN FOR APPROXIMATELY 50 PTS SAMPLES. ELEVEN EXAMPLES WERE PROVIDED. SAMPLE 1 INITIAL RESULT 94 MG/DL, REPEAT 11 MG/DL. SAMPLE 2 INITIAL RESULT 112 MG/DL, REPEAT 10 MG/DL. SAMPLE 3 INITIAL RESULT 57 MG/DL, REPEAT 17 MG/DL. SAMPLE 4 INITIAL RESULT 130 MG/DL, REPEAT 56 MG/DL. SAMPLE 5 INITIAL RESULT 86 MG/DL, REPEAT 31 MG/DL. SAMPLE 6 INITIAL RESULT 100 MG/DL, REPEAT 10 MG/DL. SAMPLE 7 INITIAL RESULT 68 MG/DL, REPEAT 10 MG/DL. SAMPLE 8 INITIAL RESULT 84 MG/DL, REPEAT 4 MG/DL. SAMPLE 9 INITIAL RESULT 105 MG/DL, REPEAT 15 MG/DL. SAMPLE 10 INITIAL RESULT 29 MG/DL, REPEAT 13 MG/DL. SAMPLE 11 INITIAL RESULT 48 MG/DL, REPEAT 8 MG/DL. ERRONEOUS RESULTS WERE REPORTED AND WERE QUESTIONED BY A PHYSICIAN. USER SENT OUT CORRECTED REPORTS ON ALL AFFECTED SAMPLES. USER IS NOT AWARE OF ANY ACTIONS TAKEN BASED ON THE INITIAL VALUES REPORTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A PROBLEM WITH THE VACUUM WASTE SYSTEM PERFORMANCE. HE REMOVED, CLEANED AND REINSTALLED THE WASTE SYSTEM VALVES, REPLACED THE WASTE VACUUM MANIFOLDS, I-JOINTS, DRAIN VALVES, VACUUM PUMP DIAPHRAGMS AND VACUUM TUBING TO WASTE. PERFORMANCE TESTS WERE PERFORMED WHICH WERE WITHIN SPECIFICATION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ANALYTICAL D MODULE CLINICAL CHEMISTRY ANALYZER-JJE JJE ROCHE DIAGNOSTICS

Patients

Seq Age Sex Outcome Treatment
1 UNK