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	03/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable alanine aminotransferase acc.To ifcc w/ pyridoxal phosphate activation results for 1 patient sample on a cobas c 303 analytical unit.The serum result was 21.8 u/l and the li heparin result was 13 u/l.The li-heparin result was reported outside of the laboratory because this result corresponded to the patient's clinical picture.
Additional Manufacturer Narrative
The clotting time for the serum tubes was 30 minutes and the centrifugation speed was 4000 u/min (2755 rcf) for 10 minutes.There were no other hints/cases of systematic discrepancies between serum and plasma.The calibration and qc were acceptable.Due to the lack of information, further investigation could not be performed.

• 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: 19018962
• Report Number: 1823260-2024-00991
• Device Sequence Number: 15448938
• Product Code: CKA
• UDI-Device Identifier: 07613336120989
• UDI-Public: 07613336120989
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 06/13/2024

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: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2024
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 06/13/2024
• 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
• Patient Sex: Unknown