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

Catalog Number	03333701190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with alp2 alkaline phosphatase acc.To ifcc gen.2 on a cobas 6000 c (501) module (serial number (b)(4)).No incorrect results were reported outside of the laboratory.The sample initially resulted in an alp value of 386 u/l and repeated as 316 u/l.The sample was re-centrifuged twice and repeated five times with all results around 200 u/l.
Additional Manufacturer Narrative
The investigation determined the issue is consistent with a high leukocyte concentration in the sample, leading to an accumulation of cells close to the plasma surface.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 14979694
• Report Number: 1823260-2022-02034
• Device Sequence Number: 5098431
• Product Code: CJE
• UDI-Device Identifier: 04015630919505
• UDI-Public: 04015630919505
• 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): 08/05/2022

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: 01/31/2023
• Device Catalogue Number: 03333701190
• Device Lot Number: 63164401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2022
• Supplement Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 07/11/2022
• Supplement Report FDA Received Date: 08/05/2022
• 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