MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2; NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES

Catalog Number	03333701190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 6000 c 501 serial number was (b)(6) the investigation is ongoing.
Event or Problem Description
There was an allegation of questionable alkaline phosphatase acc.To ifcc gen.2 results from the cobas 6000 c 501 analyzer.The initial result was 130 u/l.This result was questioned as it did not compare to the previous day's result.The repeat results from another cobas c501 analyzer were 94 u/l and 83 u/l.The repeat result from the original cobas c501 analyzer was 84 u/l.This result was believed to be correct.No questionable result was reported outside of the laboratory.
Additional Manufacturer Narrative
The provided centrifugation settings were lower than recommended by the tube manufacturer.Correct pre-analytic sample handling is within the customer's responsibility.The analyzer alarm trace did not contain any conspicuous events.As the calibration and qc were acceptable, there is no indication of a performance issue with the reagent.The investigation was unable to determine a specific root cause.The customer reported no further issues.There is no evidence to suggest a malfunction of the device.

• Brand Name: ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2
• Common Device Name: NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES
• 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: 24020155
• Report Number: 1823260-2026-00121
• Device Sequence Number: 8970263
• Product Code: CJE
• UDI-Device Identifier: 04015630919505
• UDI-Public: 04015630919505
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K033185
• 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): 03/18/2026

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: 03/31/2026
• Device Catalogue Number: 03333701190
• Device Lot Number: 89017001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2025
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 03/18/2026
• 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 Age: 77 YR
• Patient Sex: Female