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

Catalog Number	08056757190
Medical Device Problem Codes	Incorrect Measurement (1383); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas c 503 analytical unit serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable alkaline phosphatase (alp) results from the cobas c 503 analytical unit.The initial result was 188 u/l and the repeat results were 86.9 u/l and 87 u/l.The questionable result was not reported outside of the laboratory.The repeat result was believed to be correct.
Additional Manufacturer Narrative
A general reagent-specific issue was unlikely since calibration and qc data were acceptable.The investigation determined the issue was due to pre-analytical handling issues at the customer site.Correct pre-analytic sample handling is within the customer's responsibility.The investigation did not identify a product problem.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21084192
• Report Number: 1823260-2025-00038
• Device Sequence Number: 6888679
• Product Code: CJE
• UDI-Device Identifier: 07613336120972
• UDI-Public: 07613336120972
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2025

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 Catalogue Number: 08056757190
• Device Lot Number: 822628
• 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: 12/18/2024
• Supplement Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 01/08/2025
• 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
• Patient Sex: Unknown