MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ALP2 ALP IFCC GEN.2; NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES

Catalog Number	03333752190
Medical Device Problem Codes	High Test Results (2457); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas integra 400 plus serial number was (b)(6).Investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 4 patients' samples tested with alkaline phosphatase gen.2 (alp2) assay on a cobas integra 400 plus analyzer.Sample 1: initial result: 275 u/l.Rerun result: 74.14 u/l.Sample 2: initial result: 265 u/l.Rerun result: 67.98 u/l.Sample 3: initial result: 308 u/l.Rerun result: 80.26 u/l.Sample 4: initial result: 250 u/l.Rerun result: 64.58 u/l.The physician questioned the results and the samples were rerun.
Additional Manufacturer Narrative
The medical device problem code was updated.Based on the limited information provided, the cause of the event could not be determined.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: 17806551
• Report Number: 1823260-2023-03079
• Device Sequence Number: 6727409
• Product Code: CJE
• UDI-Device Identifier: 04015630919512
• UDI-Public: 04015630919512
• Combination Product (Y/N): Y
• Initial Reporter Country: TC
• 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): 12/01/2023

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: 01/31/2024
• Device Catalogue Number: 03333752190
• Device Lot Number: 724589
• 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: 09/01/2023
• Supplement Date Received by Manufacturer: 11/08/2023
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 12/01/2023
• 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