MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ALANINE AMINOTRANSFERASE ACC. TO IFCC W/ PYRIDOXAL PHOSPHATE ACTIVATION; ALT/SGPT TEST

Catalog Number	08056773190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The customer suspects and interfering substance in the patient's samples as the patient's serum has an orange color.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable altlp alanine aminotransferase acc.To ifcc with pyridoxal phosphate activation results for 3 samples from the sample patient on a cobas c 503 analytical unit.On (b)(6) 2024, sample 1 had an initial altp result of 318 u/l.A 1:50 dilution was performed on the sample and the result was 733 u/l.On (b)(6) 2024, sample 2 had an initial altp result was 793 u/l.Clarification on whether this result was obtained from a 1:10 dilution of the sample was requested but not provided.A 1:50 dilution was performed on the sample and the result was 1229 u/l.On (b)(6) 2024, sample 3 had an initial altp result was 477 u/l.A 1:50 dilution was performed on the sample and the result was 996 u/l.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The root cause of the event could not be determined.
Additional Manufacturer Narrative
On (b)(6) 2024, the affiliate clarified that the initial altp result of 793 u/l was obtained from an automatic 1:10 dilution.

• Brand Name: ALANINE AMINOTRANSFERASE ACC. TO IFCC W/ PYRIDOXAL PHOSPHATE ACTIVATION
• Common Device Name: ALT/SGPT TEST
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 19341959
• Report Number: 1823260-2024-01484
• Device Sequence Number: 7142977
• Product Code: CKA
• UDI-Device Identifier: 07613336120989
• UDI-Public: 07613336120989
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• PMA/510(K) Number: K954992
• 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): 08/13/2024

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 Catalogue Number: 08056773190
• Device Lot Number: 785551
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 05/21/2024; 07/24/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 05/21/2024; 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: AMANTADINE; CO AMOXICLAV; DALTEPARIN; ENTACAPONE; RASAGILINE; REPINEX; ROPINIROLE; SINEMET (CO-CARELDOPA)
• Patient Sex: Unknown