MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ALTPM-ALANINE AMINOTRANSFERASE; NADH OXIDATION/NAD REDUCTION, ALT/SGPT

Catalog Number	05531462190
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received questionable results accompanied by data flags for one patient sample tested with the altpm-alanine aminotransferase assay on a cobas 8000 c702 module, serial number (b)(4).The sample initially resulted in a value of 56.6 u/l, accompanied by a data flag.The sample was repeated resulting in a value of 58.1 u/l, accompanied by a data flag.The sample was repeated on a second c702 analyzer, resulting in an unknown value, accompanied by a data flag.The assay was performed on heparinized plasma out of the primary tube.No questionable result was reported outside of the laboratory.An interference is suspected.
Additional Manufacturer Narrative
Medwatch fields b6 and b7 have been updated.
Additional Manufacturer Narrative
Calibration and quality controls were acceptable.A general reagent issue can be excluded.Gammopathy and drug interferences have been excluded.The sample was not available for further investigation.Based on the available information the most probable root cause is lipemic samples due to the disease status (severe liver damage and other problems).The investigation did not identify a product problem.The issue is consistent with a sample-specific root cause, related to the medical condition of the patient.

• Brand Name: ALTPM-ALANINE AMINOTRANSFERASE
• Common Device Name: NADH OXIDATION/NAD REDUCTION, ALT/SGPT
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15907053
• Report Number: 1823260-2022-03844
• Device Sequence Number: 5391068
• Product Code: CKA
• UDI-Device Identifier: 04015630927425
• UDI-Public: 04015630927425
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 05531462190
• Device Lot Number: 65276501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2022
• Supplement Date Received by Manufacturer: 12/07/2022; 07/07/2023
• Initial Report FDA Received Date: 12/02/2022
• Supplement Report FDA Received Date: 12/29/2022; 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ABASAGLAR - 1X/DAY; AMIODARONE - 1X/DAY; ASPIRIN - 1X/DAY; BISOPROLOL - 2X/DAY; EPLERENONE - 1X/DAY; FLUCONAZOLE - 1X/DAY; FUROSEMIDE - 1X/DAY; INNOHEP - 1 INJECTION/DAY; LANZOPRAZOLE - 1X/DAY; LASIX; MACROGOL - AS NEEDED; NOVORAPID - 3X/DAY; PARACETAMOL - AS NEEDED; RAMIPRIL - 1X/DAY; RISORDAN; SITAGLIPTINE - 1X/DAY
• Patient Age: 61 YR
• Patient Sex: Male