MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ALTP; ALT/SGPT

Catalog Number	08056773190
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The altp reagent expiration date was not provided.The cobas pure c303 analytical unit serial number was (b)(6).Calibration and qc were acceptable.The investigation is ongoing.
Event or Problem Description
We received an allegation about questionable results for 1 patient's serum/plasma sample tested with alanine aminotransferase (altp) assay on a cobas pure c303 analytical unit.The sample was tested in 3 tubes.The below results were obtained when using two different lithium heparin tubes: initial result: -1.70 u/l (accompanied by a data flag).The sample was then repeated.The following repeat results were obtained and they were all accompanied by a data flag: 1.47 u/l.0.683 u/l.2.77 u/l.4.10 u/l.The result of -1.41 u/l (accompanied by a data flag) was obtained when the k2 edta tube was used.The customer suspected an interference since the obtained measurements were negative.
Additional Manufacturer Narrative
Sections a2 and b7 were updated.The concomitant medical product section was also updated.A general reagent issue can be excluded since qc was within ranges.The patient was taking an analgesic and the name of the analgesic was requested but not provided.Since the exact compound was not provided, further investigation regarding the suspected interference could not be performed.The investigation determined no interference from common analgetic drugs: phenylbutazone, acetylsalicylic acid, acetaminophen, and ibuprofen.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ALTP
• Common Device Name: ALT/SGPT
• 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: 18802655
• Report Number: 1823260-2024-00583
• Device Sequence Number: 7168883
• Product Code: CKA
• UDI-Device Identifier: 07613336120989
• UDI-Public: 07613336120989
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• PMA/510(K) Number: K801119
• 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): 04/10/2024

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: 773158
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2024
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 02/28/2024
• Supplement Report FDA Received Date: 04/10/2024
• 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: ANALGESIC; ANALGESIC
• Patient Age: 37 YR
• Patient Sex: Unknown