MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS INTEGRA 400 PLUS; CLINICAL CHEMISTRY ANALYZER

Model Number I400+

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer stated that they received questionable results for three patient samples tested for crep2 creatinine plus ver.2 (crep) on a cobas integra 400 plus (i400+) analyzer.Of the three samples, two had erroneous crep results.No erroneous results were reported outside of the laboratory.The first sample resulted with crep values of 68.1 umol/l, 94.8 umol/l, and 68.6 umol/l.On (b)(6) 2018, the second sample resulted with crep values of 87.0 umol/l, 85.6 umol/l, and 135.9 umol/l.No adverse events were alleged to have occurred with the patients.The crep reagent lot number was 328252.The reagent expiration date was asked for, but not provided.

Manufacturer Narrative

An extra wash cycle was programmed on the analyzer on (b)(6) 2018.The customer stated that they had a discrepancy with results from an additional sample after this date.No further information was provided with relation to this sample discrepancy.The investigation was unable to find a definitive root cause.

• Brand Name: COBAS INTEGRA 400 PLUS
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7568548
• MDR Text Key: 110044197
• Report Number: 1823260-2018-01738
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• PMA/PMN Number: K951595
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: I400+
• Device Catalogue Number: 03245233001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1