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	03/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable alkaline phosphatase (alp2) results from the cobas c 503 analytical unit.Patient 1 initial result was 419 ui/l and the repeat results were 708 ui/l and 524 ui/l.On (b)(6) 2024, patient 2 initial result was 372 ui/l and the repeat results were 222 ui/l and 198 ui/l after recentrifugation.
Additional Manufacturer Narrative
The cobas c 503 analytical unit serial number was (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The customer alleged discrepant alkaline phosphatase (alp2) results for additional patient samples.Sample (b)(6) initial result was 243 ui/l and the repeat result was 86 ui/l.Sample (b)(6) initial result was 317 ui/l and the repeat result was 178 ui/l.Sample (b)(6) initial result was 303 ui/l and the repeat result was 128 ui/l.Sample (b)(6) initial result was 217 ui/l and the repeat result was 142 ui/l.The investigation is ongoing.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The specific cause of the event could not be determined.The issue was consistent with a high leukocyte concentration in the samples leading to an accumulation of cells close to the plasma surface.Therefore, the most likely root cause is related to preanalytics/sample related.Correct pre-analytic sample handling is within the customer's responsibility.

• 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: 19019393
• Report Number: 1823260-2024-01000
• Device Sequence Number: 4021191
• 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,Followup
• Report Date (Section B): 09/26/2024

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): Follow-Up
• Initial Date Received by Manufacturer: 03/13/2024
• Supplement Date Received by Manufacturer: 04/05/2024; 09/25/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 04/26/2024; 09/26/2024
• 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