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	09/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient sample tube had a high level of white cells inside before centrifugation at 18000 gb/mm3.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable alp2 alkaline phosphatase results for one patient sample tested on two cobas 6000 c501 modules.It is unknown if the initial result was reported outside of the laboratory.The sample was initially run on a cobas analyzer.As the results showed a pathologic level, the patient sample was rerun on the two cobas 6000 c501 modules (module 1 and module 2).The initial result from the cobas analyzer was 195 ui/l with a data flag that invalidated the result.The first repeat result from the cobas analyzer by automatic rerun was 238 ui/l.The second repeat result from module 1 was 132.2 ui/l.The third repeat result from module 2 was 138 ui/l.The fourth repeat result from module 2 was 288 ui/l.It is likely that the low results (132.2 & 138 iu/l) were correct.
Additional Manufacturer Narrative
Medwatch fields a2, a4, b6, b7 and d10 have been updated.
Additional Manufacturer Narrative
The alp calibration and qc data are acceptable.A general reagent issue can be excluded as the root cause.All of the alp results for other patient samples are not affected.A hardware issue is unlikely.Based on the information provided, the investigation determined that the event was consistent with a sample-specific issue.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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15644379
• Report Number: 1823260-2022-03275
• Device Sequence Number: 14051927
• Product Code: CJE
• UDI-Device Identifier: 07613336120972
• UDI-Public: 07613336120972
• 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): N
• 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): 05/02/2023

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: 09/30/2022
• Device Catalogue Number: 08056757190
• Device Lot Number: 60794901
• 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: 09/23/2022
• Supplement Date Received by Manufacturer: 10/25/2022; 04/24/2023
• Initial Report FDA Received Date: 10/20/2022
• Supplement Report FDA Received Date: 11/17/2022; 05/02/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AUGMENTIN; COLIMYCIN AEROSOL; FUROSEMIDE; MORPHINE AT 0.3MG/HOUR; TAZOCILLIN; UNDER OXYGEN 5 LITERS
• Patient Age: 82 YR
• Patient Sex: Unknown
• Patient Weight: 46 KG