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	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable alp2 alkaline phosphatase acc.To ifcc gen.2 results for 1 patient plasma sample on a cobas c 503 analytical unit.The initial alp2 result was 387 u/l.The repeat result was 167 u/l.The sample recentrifuged and was repeated again and the result was 154 u/l.
Additional Manufacturer Narrative
The calibration and qc recovery data provided were acceptable.The investigation determined the event was consistent with a preanalytic issue at the customer site (high leukocyte concentration in the patient sample leading to an accumulation of cells close to the plasma surface causing higher alp activity).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: 19192772
• Report Number: 1823260-2024-01293
• Device Sequence Number: 7640435
• Product Code: CJE
• UDI-Device Identifier: 07613336120972
• UDI-Public: 07613336120972
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• 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): 10/15/2024

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: 08056757190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 10/15/2024
• 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