MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ALP2 ALP 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	10/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of discrepant results for 1 patient sample tested for alp2 (alp ifcc gen.2) on a cobas 6000 c501 module.The initial result was 177 ui/l.Since a prior result for the patient from (b)(6) 2023 was 88 ui/l the customer¿s laboratory information system (lis) requested an automatic repeat and the result was 119 ui/l.The customer repeated the sample on another cobas 6000 line and the results were 104 ui/l and 94 ui/l.These results were believed to be correct.
Additional Manufacturer Narrative
The c501 module serial number was (b)(6).Qc was acceptable.
Additional Manufacturer Narrative
The patient has a high white blood cell count of 31 g/l.High alkaline phosphatase (alp) results can be due to a high leukocyte concentration leading 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.The investigation did not identify a product problem.

• Brand Name: ALP2 ALP 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: 18158760
• Report Number: 1823260-2023-03648
• Device Sequence Number: 18142425
• Product Code: CJE
• UDI-Device Identifier: 04015630919505
• UDI-Public: 04015630919505
• 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): 10/03/2024

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 Expiration Date: 02/29/2024
• Device Catalogue Number: 03333701190
• Device Lot Number: 73043901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2023
• Supplement Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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