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

Catalog Number	08104697190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with altp gen.2 on a cobas c 503 analytical unit.The sample initially resulted in an alt value of 7.06 u/l.The sample was repeated, resulting in an alt value of 11.0 u/l accompanied by a data flag indicating a reaction issue.The sample was repeated using decreased sample volume, resulting in an alt value of > 8069 u/l accompanied by a data flag.The sample was repeated, resulting in an alt value of 9.54 u/l accompanied by a data flag indicating a reaction issue.The sample was diluted 1:10 and repeated, resulting in an alt value of > 8097 u/l accompanied by a data flag.The sample was diluted 1:50 and repeated on (b)(6) 2025, resulting in an alt value of 9124 u/l.
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).A review of the alarm trace showed sample related alarms.Calibration data was acceptable.Control data was acceptable.Control data showed that controls were outside of range on 28-may-2025 and 29-may-2025.A review of analyzer data showed that laboratory humidity was not at a stable level.Laboratory temperature was acceptable.The investigation is ongoing.
Additional Manufacturer Narrative
Medwatch fields b7 and d10 have been updated.
Additional Manufacturer Narrative
The investigation determined the issue is consistent with the patient's condition, leading to a very high alt concentration in the patient's sample.Malignant hyperthermia (mh) is a serious genetic condition that can lead to a rapid increase in body temperature and muscle breakdown.This can cause rhabdomyolysis, a condition where damaged muscle tissue releases proteins and electrolytes into the blood.Rhabdomyolysis can significantly elevate liver enzymes, including alt and ast, as a result of muscle damage and secondary liver injury.The multiple organ failure and the emergency liver transplant also strongly suggest a severe liver injury, which would be reflected in a very high alt value.With extremely high transaminase concentrations, the nadh is used up before the measurement window begins.Normally, a system flag is triggered in such cases.However, if cloudiness occurs during the measurement, the flag may not activate.This results in a falsely low, unflagged result.

• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 22644662
• Report Number: 1823260-2025-02334
• Device Sequence Number: 8632791
• Product Code: CKA
• UDI-Device Identifier: 07613336130513
• UDI-Public: 07613336130513
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 11/26/2025

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 Expiration Date: 05/31/2026
• Device Catalogue Number: 08104697190
• Device Lot Number: 88078201
• 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: 07/09/2025
• Supplement Date Received by Manufacturer: 08/14/2025; 11/10/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 09/04/2025; 11/26/2025
• 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: COTRIMOXAZOLE (TUESDAYS AND FRIDAYS); FUROSEMIDE (1-1-0); HEPARIN CALCIUM (EVERY 12 HOURS); MYCOPHENOLATE MOFETIL (1-0-1); TACROLIMUS (1-0-1); VALGANCICLOVIR (TUESDAYS, THURSDAYS, FRIDAYS); ZOPICLONE (0-0-0-1)
• Patient Sex: Male