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

Catalog Number	07028121190
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer stopped using the affected reagent pack and replaced it with a new one.Controls and patient results were ok with the new pack.
Event or Problem Description
The initial reporter stated that on (b)(6) 2022, calibration and controls were out of limits after loading a new elecsys vitamin b12 gen.2 immunoassay reagent pack on a cobas 8000 e 801 module (serial number (b)(4).After several attempts at running calibration and controls, the assay was changed to the second measuring channel of the analyzer and controls recovered near the target.On (b)(6) 2022, the customer measured only one level of control and it was near the target.Later that morning, the customer noticed that almost all vitamin b12 patient results were 100 pg/ml.After this observation, the customer ran both control levels and results were outside of range.The customer then repeated an unspecified number of patient samples on a second analyzer and the results were significantly different.The customer provided an example of one patient sample with discrepant vitamin b12 results.No incorrect results were reported outside of the laboratory.The sample initially resulted in a vitamin b12 result of 100 pg/ml and repeated as 196 pg/ml.
Additional Manufacturer Narrative
The customer provided data for five additional patient samples that were involved in the event and had discrepant vitamin b12 results.The second patient sample initially resulted in a vitamin b12 result of 100 pg/ml and repeated as 262 pg/ml.The third patient sample initially resulted in a vitamin b12 result of 100 pg/ml and repeated as 153 pg/ml.The fourth patient sample initially resulted in a vitamin b12 result of 100 pg/ml and repeated as 273 pg/ml.The fifth patient sample initially resulted in a vitamin b12 result of 100 pg/ml and repeated as 227 pg/ml.The sixth patient sample initially resulted in a vitamin b12 result of 100 pg/ml and repeated as 270 pg/ml.
Additional Manufacturer Narrative
The affected reagent pack was calibrated on 13-may-2022 and had signals that were lower than expected.Signals were within expectations for a new reagent pack calibrated on 16-may-2022.On the day of the event, only one control level was measured in the morning with the affected reagent pack.In the afternoon, one level of control was outside of range and the second level was within range, but near the lower limit with the affected reagent pack.The last control measurements occurred on 13-may-2022.Per product labeling: "controls for the various concentration ranges should be run individually at least once every 24 hours when the test is in use, once per cobas e pack, and following each calibration.The control intervals and limits should be adapted to each laboratory¿s individual requirements.Values obtained should fall within the defined limits.Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.If necessary, repeat the measurement of the samples concerned." the investigation could 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14605682
• Report Number: 1823260-2022-01638
• Device Sequence Number: 5164849
• Product Code: CDD
• UDI-Device Identifier: 04015630939848
• UDI-Public: 04015630939848
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K060755
• 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,Followup
• Report Date (Section B): 08/01/2022

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: 12/31/2022
• Device Catalogue Number: 07028121190
• Device Lot Number: 53846303
• 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: 05/17/2022
• Supplement Date Received by Manufacturer: 05/24/2022; 07/06/2022
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 06/16/2022; 08/01/2022
• 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