MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS VITAMIN B12 II; RADIOASSAY, VITAMIN B12

Catalog Number	07028121190
Medical Device Problem Codes	Incorrect Measurement (1383); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys vitamin b12 immunoassay results for several patient samples tested on an unspecified cobas 8000 analyzer with an unknown serial number.The initial results were reported outside of the laboratory.On (b)(6) 2022, the reporter noticed that the vitamin b12 results were low and were not confirmed by the holotranscobalamin or methylmalonic acid (mma) measurement.The reporter sent the samples to another laboratory that used the same reagent and calibrator lot.On (b)(6) 2022, the customer used a second reagent lot and reran the samples on the analyzer.Sample 3 was also rerun on another cobas analyzer.The vitamin b12 results were as expected and were compatible with holotranscobalamin.The following are examples of discrepant results for 3 patient samples: sample 1's initial result from the analyzer was 124 pmol/l.The first repeat result from the other laboratory was 174 pmol/l.The second repeat result from the analyzer using the second reagent lot was 150 pmol/l.The third repeat result from the analyzer using the second reagent lot was 131 pmol/l.Sample 2's initial result from the analyzer was 110 pmol/l.The repeat result from the other laboratory was 156 pmol/l.The second repeat result from the analyzer using the second reagent lot was 128 pmol/l.The third repeat result from the analyzer using the second reagent lot was 107 pmol/l.Sample 3's initial result from the analyzer using the first reagent lot was 107 pmol/l.The first repeat result from the other laboratory that used the first reagent lot was 148 pmol/l.The second repeat result from the analyzer using the second reagent lot was 127 pmol/l.The third repeat result from the analyzer using the second reagent lot was 127 pmol/l.The fourth repeat result from the analyzer using the second reagent lot was 136 pmol/l.The fifth repeat result from the analyzer using the second reagent lot was 140 pmol/l.The sixth repeat result from the other analyzer using the second reagent lot was 110 pmol/l.The seventh repeat result from the analyzer using the second lot was 129 pmol/l.The eighth repeat result from the analyzer using the second reagent lot was 115 pmol/l.The second reagent lot number used was 63305200.The expiration date was requested but not provided.
Additional Manufacturer Narrative
The calibration for lot number 58456701 for all analyzers was within specifications.Based on the provided information, it is unclear which calibration was valid for the complained results.Therefore, a more detailed analysis is not possible.The calibration for lot number 63305200 for all analyzers was within expectations.The qcs were all within the specified ranges.The customer¿s mean qc recovery (especially for level 1) was noted to be slightly lower than the global mean recovery, and to some extent on different analyzers.A general reagent issue with vitamin b12 ii with lot number 58456701 can be excluded because the customer¿s qc data was within specifications, the global recovery data did not suggest an issue and the patient sample results from the other laboratory using the same lot were considered correct.The investigation did not identify a product problem.The cause of the event could not be determined. .

• Brand Name: ELECSYS VITAMIN B12 II
• Common Device Name: RADIOASSAY, VITAMIN B12
• 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: 15053480
• Report Number: 1823260-2022-02133
• Device Sequence Number: 20026972
• Product Code: CDD
• UDI-Device Identifier: 04015630939848
• UDI-Public: 04015630939848
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K060755
• 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
• Report Date (Section B): 10/05/2022

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: 05/31/2023
• Device Catalogue Number: 07028121190
• Device Lot Number: 58456701
• 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: 06/24/2022
• Supplement Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 07/19/2022
• Supplement Report FDA Received Date: 10/05/2022
• 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