MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ALTL ALANINE AMINOTRANSFERASE - PYRIDOXAL PHOPHATE ACTIVATED; NADH OXIDATION/NAD REDUCTION, ALT/SGPT

Catalog Number ASKU

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/09/2018

Event Type  malfunction  

Manufacturer Narrative

The event occurred in: (b)(6).

Event Description

The customer originally complained about questionable crep2 creatinine plus ver.2 tested on both a cobas 6000 c (501) module and a cobas 8000 (unspecified module) compared to an abbott system.From the data provided, a reportable malfunction was provided for crep2, astlp aspartate aminotransferase acc.To ifcc with pyridoxal phosphate activation, altlp alanine aminotransferase acc.To ifcc with pyridoxal phosphate activation, and ggt-2 -glutamyltransferase ver.2 standardized against ifcc / szasz.This medwatch will cover altlp.Please refer to the medwatch with (b)(6) for information on astlp.Please refer to the medwatch with (b)(6) for information on ggt-2.Please refer to the medwatch with (b)(6) for information on crep2.The erroneous results were released outside of the laboratory.The patient was sent to the hospital due the initial high crep2 result, but there was no allegation that the patient was adversely affected.The cobas c501 serial (b)(4).The customer did not provide any specific information on the cobas 8000 system.A preliminary assessment of the case stated that based on previous electrophoresis testing of the patient, the patient is believed to have an interfering factor present.The investigation is currently ongoing.

Manufacturer Narrative

The customer's cobas 8000 model used was a c701.The patient sample was received for further investigation.The results from the investigation have results indicative of a monoclonal gammopathy.Clarification was requested if this interference could have caused the discrepant results observed but clarification was not provided.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ALTL ALANINE AMINOTRANSFERASE - PYRIDOXAL PHOPHATE ACTIVATED
• Type of Device: NADH OXIDATION/NAD REDUCTION, ALT/SGPT
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7827930
• MDR Text Key: 119041719
• Report Number: 1823260-2018-02916
• Device Sequence Number: 1
• Product Code: CKA
• UDI-Device Identifier: 04015630920532
• UDI-Public: 4015630920532
• 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: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BACTRIM; INEXIUM; KARDEGIC; LEDERFOLINE; MILLEPERTUIS; PRETERAX; TAHOR; ZELITREX
• Patient Age: 80 YR