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

Catalog Number	08056757190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer was aware of variability in alp results for patient samples with a high white blood cell count and repeated the sample.For samples with high white blood cell concentrations, high leukocyte concentration of the sample leads to an accumulation of cells close to the plasma surface.In samples with hyper-leukocytosis, the sample surface may show higher alp activity due to the presence of leukocytes, debris, and platelets.Questionable high alp results can occur if blood cells or cell debris are not properly removed in the pre-analytical sampling process.The investigation did not identify a product problem.
Additional Manufacturer Narrative
The c503 analyzer serial numbers were (b)(6) (analyzer a) and (b)(6) (analyzer b).
Event or Problem Description
The initial reporter complained of discrepant results for 1 patient sample tested for alkaline phosphatase acc.To ifcc gen.2 (alp2) on two cobas c 503 analytical units.The initial result from c503 analyzer a was 116 u/l.The repeat result from c503 analyzer a was 92.1 u/l.The initial result from c503 analyzer b was 215 u/l.The repeat result from c503 analyzer b was 75.5 u/l.The sample was repeated on both analyzers after re-centrifugation, and the results were 68.8 u/l and 68.5 u/l.

• 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: 22087052
• Report Number: 1823260-2025-01605
• Device Sequence Number: 12499548
• Product Code: CJE
• UDI-Device Identifier: 07613336120972
• UDI-Public: 07613336120972
• Combination Product (Y/N): N
• 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): 06/25/2025

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: 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: 05/05/2025
• Supplement Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 06/25/2025
• 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