FDA Adverse Event Malfunction Summary report: N

COBAS INTEGRA 800

MDR report key: 958639 · Received November 30, 2007

Report

Report Number
1823260-2007-10346
Event Type
Malfunction
Date Received
November 30, 2007
Date of Event
July 6, 2007
Report Date
November 30, 2007
Manufacturer
ROCHE DIAGNOSTICS
Product Code
JJE
PMA / PMN Number
K951595
Product Problem
Yes
Report Source
Manufacturer report
Reporter Occupation
HEALTH PROFESSIONAL

Narratives

Description of Event or Problem · 1

CUSTOMER EXPERIENCING DISCREPANT PT SODIUM RESULTS, SINCE 2007. THE FOLLOWING PT EXAMPLES WERE PROVIDED. THE SAME DAY, PT 1 INITIAL RESULT GAVE 125 MMOL/L; REPEATED TWO TIMES GIVING 133 AND 132 MMOL/L RESPECTIVELY. TWELVE DAYS LATER, PT 2 INITIAL RESULT GAVE 120 MMOL/L; REPEATED TWO TIMES GIVING 126 AND 126 MMOL/L RESPECTIVELY. THE NEXT MONTH, PT 3 INITIAL RESULT GAVE 125 MMOL/L; REPEATED SEVEN TIMES GIVING 120, 124, 125, 126, 125, 126 AND 124 MMOL/L RESPECTIVELY. PT 4 INITIAL RESULT GAVE 131 MMOL/L ; REPEATED SEVEN TIMES GIVING 126, 132, 132, 132, 128, 132 AND 129 MMOL/L RESPECTIVELY. THREE WEEKS LATER, PT 5 INITIAL RESULT GAVE 133 MMOL/L; REPEATED TWO TIMES GIVING 130 AND 124 MMOL/L RESPECTIVELY. PT 6 INITIAL RESULT GAVE 129 MMOL/L; REPEATED TWO TIMES GIVING 120 AND 125 MMOL/L RESPECTIVELY. PT 7 INITIAL RESULT GAVE 131 MMOL/L; REPEATED TWO TIMES GIVING 122 AND 125 MMOL/L RESPECTIVELY. PT 8 INITIAL RESULT GAVE 119 MMOL/L; REPEAT GAVE 112 MMOL/L. THE FOLLOWING MONTH, PT 9 INITIAL RESULT GAVE 126 MMOL/L; REPEATED FOUR TIMES GIVING 128, 135, 134 AND 135 MMOL/L RESPECTIVELY. PT 10 INITIAL RESULT GAVE 126 MMOL/L; REPEATED NINE TIMES GIVING 131, 131, 131, 131, 131, 132, 131, 131 AND 131 MMOL/L RESPECTIVELY. TWO DAYS LATER, PT 11 INITIAL RESULTS GAVE 115 MMOL/L; REPEATED FOUR TIMES GIVING 119, 121, 125 AND 125 MMOL/L RESPECTIVELY. THREE WEEKS LATER, PT 12 INITIAL RESULT GAVE 132 MMOL/L; REPEATED TWO TIMES GIVING 124 AND 133 MMOL/L RESPECTIVELY. THE NEXT MONTH, PT 13 INITIAL RESULT GAVE 124 MMOL/L; REPEATED TWO TIMES GIVING 132 AND 131 MMOL/L RESPECTIVELY. PT 14 INITIAL RESULT GAVE 131 MMOL/L; REPEATED TWO TIMES GIVING 117 AND 130 MMOL/L RESPECTIVELY. SEVEN DAYS LATER, PT 15 INITIAL RESULT GAVE 123 MMOL/L; REPEATED TWO TIMES GIVING 131 AND 123 MMOL/L RESPECTIVELY. ON 10/28/2007, PT 16 INITIAL RESULT GAVE 125 MMOL/L; REPEATED TEN TIMES GIVING 131, 131, 130, 131, 130, 130, 131, 130, 131 AND 130 MMOL/L RESPECTIVELY. IF ADD'L INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 COBAS INTEGRA 800 CLINICAL CHEMISTRY ANALYZER-JJE JJE ROCHE DIAGNOSTICS I800

Patients

Seq Age Sex Outcome Treatment
1 UNK YR