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	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c303 analyzer serial number was (b)(6).Calibration and qc were acceptable.No issues were identified during a review of the alarm trace data.The investigation is ongoing.
Event or Problem Description
The initial reporter complained of discrepant high results for 1 patient sample tested for alkaline phosphatase acc.To ifcc gen.2 (alp2) a cobas c 303 analytical unit.The initial result from line 1 of the analyzer was 348 u/l with an invalidating data flag.The sample was autorepeated by the instrument with a result of 539 u/l.The sample was repeated on line 2 of the analyzer with a result of 252 u/l.The sample was repeated on line 2 with a result of 236 u/l.The customer performed repeatability testing with the patient sample on line 1 of the analyzer with results between 114 u/l and 142 u/l.The customer performed repeatability testing with the patient sample on line 2 of the analyzer with a mean result of 115.38 u/l.Following repeatability testing, a result of 120 iu/l was reported outside of the laboratory.
Additional Manufacturer Narrative
A general reagent issue has been excluded as qc was within specification.The patient has a high white blood cell count of 61.2 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: 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: 18148730
• Report Number: 1823260-2023-03626
• Device Sequence Number: 20735254
• 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): 10/03/2024

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: 04/30/2024
• Device Catalogue Number: 08056757190
• Device Lot Number: 73631801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2023
• Supplement Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 11/16/2023
• 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