MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ALTP GEN.2; ALT/SGPT

Catalog Number	08104697190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458); Insufficient Device Problem Information (3190); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The instrument's serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable altp gen.2 results for 2 patient samples and questionable lactate dehydrogenase acc.Ifcc ver.2 results for 1 patient sample on a cobas c 503 analytical unit.Altp results: patient 1: the initial result was 54 u/l.The result with the new reagent lot was 95 u/l.The repeated result with the initial reagent lot was 114 u/l.Patient 2: the initial result was 236 u/l.The result with the new reagent lot was 427 u/l.The repeated result with the initial reagent lot was 429 u/l.Ldh results: patient 3: on (b)(6) 2024, the initial result was 885 u/l.The result with the new reagent lot was 518 u/l.The repeated result with the initial reagent lot was 564 u/l.The initial results were reported outside the laboratory.The customer performed a lot-to-lot comparison study with the alleged samples using new reagent lots.The customer noticed the discrepancies and repeated the samples on another module using the same reagent lots that were used to obtain the initial results.The repeated results were believed to be correct as they were comparable with the results obtained during the lot-to-lot comparison.This medwatch will apply to the altp gen.2 assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the lactate dehydrogenase acc.Ifcc ver.2 assay.
Additional Manufacturer Narrative
The customer declined to provide any additional information.The field service engineer (fse) did not identify a cause for the event.The field application specialist (fas) performed precision testing and results were well within their established range.Based on the information provided, the cause of the event could not be determined.The investigation did not identify a product problem.

• Brand Name: ALTP GEN.2
• 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: 20894366
• Report Number: 1823260-2024-03599
• Device Sequence Number: 21009927
• Product Code: CKA
• UDI-Device Identifier: 07613336130513
• UDI-Public: 07613336130513
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2024

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: 08104697190
• Device Lot Number: 813822
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/15/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 12/27/2024
• 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