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

Catalog Number	ASKU
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
The initial reporter received a questionable altl alanine aminotransferase acc.To ifcc without pyridoxal phosphate activation result for one patient sample with a cobas 8000 c702 module.The reporter stated they were having issues obtaining valid values due to flagging on this specific patient sample and suspected an interference.The reporter provided the following results without any flagging: the initial result was 18 u/l.The repeated result was 28.5 u/l.The second repeated result was 28.4 u/l.It is unknown if the questionable result was reported outside of the laboratory.
Additional Manufacturer Narrative
The customer's qc results were acceptable.Therefore we would exclude a general reagent issue.The investigation determined the event was consistent with a gammopathic interference.Product labeling states, "in very rare cases, gammopathy, in particular type igm (waldenström¿s macroglobulinemia), may cause unreliable results.".

• Brand Name: ALTL ALANINE AMINOTRANSFERASE - PYRIDOXAL PHOPHATE ACTIVATED
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13259429
• Report Number: 1823260-2022-00126
• Device Sequence Number: 11158063
• Product Code: CKA
• UDI-Device Identifier: 04015630913862
• UDI-Public: 04015630913862
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K951595
• 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): 02/09/2022

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: ASKU
• Device Lot Number: ASKU
• 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: 12/20/2021
• Supplement Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 01/14/2022
• Supplement Report FDA Received Date: 02/09/2022
• 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: AMODIPINE; CILOSTAN CR; CLEAN VIEWAL POWDER; CRESTOR; DICAMAX; EZETROL; FENOCID; FURTMAN; GASOCOL; GODEX; LIDOCAINE; MIDAZOLAM; MYPOL; NACL; OMACOR; OMAPONE; PANTOLOC; PETHIDINE; POFOL; STILNOX; TAMIPOOL; URSA
• Patient Sex: Unknown