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	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c503 analyzer serial number was (b)(6).No issues were identified during a review of the reaction monitor data.Calibration data was acceptable.Two different alp2 reagent lot numbers were in use between 08-oct-2023 and 07-nov-2023: 728971 with an expiration date of 29-feb-2024 and 736318 with an expiration date of 30-apr-2024.It is not clear which reagent lot was used for the discrepant results on 04-nov-2023.Qc data was mostly within the acceptable range with a "few" outside the acceptable range.No issues were identified during a review of the alarm trace data provided from 04-nov-2023 and 07-nov-2023.The investigation is ongoing.
Event or Problem Description
The initial reporter questioned the results for multiple patient samples tested for alkaline phosphatase acc.To ifcc gen.2 (alp2) on a cobas c 503 analytical unit.Of the data provided for 6 patient samples, the results for 1 patient were discrepant.The initial result was 99.4 u/l.The repeat result was 119 u/l.The sample was repeated twice on a different analyzer and the results were 77.5 u/l and 77.2 u/l.The initial result was not reported outside of the laboratory.The customer runs all alp2 tests in duplicate.
Additional Manufacturer Narrative
Based on the information provided, a general lot-specific reagent issue was excluded as calibration and qc data were acceptable.The centrifugation speed is listed as 1500 relative centrifugal field (rcf).Based on the sample tubes used by the customer, the tubes should be spun at a speed of 1000 to 1300 rcf for 10 minutes.The investigation determined the event was consistent with a pre-analytical handling 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18274031
• Report Number: 1823260-2023-03879
• Device Sequence Number: 5723467
• Product Code: CJE
• UDI-Device Identifier: 07613336120972
• UDI-Public: 07613336120972
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• 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): 12/14/2023

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: 02/29/2024
• Device Catalogue Number: 08056757190
• Device Lot Number: 728971, 736318
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2023
• Supplement Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 12/06/2023
• Supplement Report FDA Received Date: 12/14/2023
• 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