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

Catalog Number 04467388190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2020

Event Type  malfunction  

Manufacturer Narrative

Sample from the patient was requested for further investigation.This event occurred in (b)(6).

Event Description

The initial reporter received questionable altl alanine aminotransferase and astlp aspartate aminotransferase results for one patient from cobas 6000 series system serial number (b)(4).The customer suspected an interference with the intravenous medication "monofer" (iron supplement).This medwatch is for altl.Refer to the medwatch with patient identifier (b)(6) for the astlp assay.The initial results were a "normal sample run".No specific data was provided.The repeat results with a 1:10 dilution were: altlp: 9 i/u with a data flag and 4 i/u with a data flag.Astlp: 12 i/u with a data flag and 29 i/u with a data flag.The repeat results were a 1:20 dilution were: altlp: 7 i/u with a data flag.Astlp: 13 i/u with a data flag.The repeat results were: altlp: 4 i/u with a data flag.Astlp: -13 i/u with a data flag.After the sample was recentrifuged, the results were: altlp: 8 i/u with a data flag and 10 i/u with a data flag.Astlp: 14 i/u with a data flag and 31 i/u with a data flag.The questionable results were not reported outside of the laboratory.

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.

Manufacturer Narrative

Testing of the returned patient sample confirmed the customer's results.The investigation could not confirm an interference with the medication monofer.As quality controls were acceptable, a general reagent issue could be excluded.

• 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: 10138787
• MDR Text Key: 203350085
• Report Number: 1823260-2020-01412
• Device Sequence Number: 1
• Product Code: CKA
• 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,Followup
• Report Date: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04467388190
• Device Lot Number: 459231
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 47 YR