MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-TG; SYSTEM, TEST, THYROID AUTOANTIBODY

Catalog Number	06368697190
Medical Device Problem Codes	Low Test Results (2458); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter changed to reagent lot 574764 (new lot) and questioned low results for 5 patient samples tested between the new reagent lot and reagent lot 595368 (old lot) for elecsys anti-tg (anti-tg) on a cobas 8000 e 602 module.The following are examples of discrepant results for 3 patient samples: patient 1 result from the new lot was 39.25 iu/ml.The result from the old lot was 292.4 iu/ml.Patient 2 result from the new lot was 57.13 iu/ml.The result from the old lot was 143.7 iu/ml.Patient 3 result from the new lot was 159.6 iu/ml.The result from the old lot was 1247 iu/ml.Questionable results were reported outside of the laboratory.The e602 module serial number was (b)(4).
Additional Manufacturer Narrative
The customer performed comparison testing for troubleshooting purposes between different reagent packs of the new reagent lot (574764) and discrepant low results were identified.For example: example 1: the result from reagent pack 45675 was 56.17 iu/ml.The result from a new reagent pack was 124.9 iu/ml.Example 2: the result from reagent pack 46353 was 47.72 iu/ml.The result from a new reagent pack was 306.8 iu/ml.Example 3: the result from reagent pack 46356 was 39.73 iu/ml.The result from a new reagent pack was 255.6 iu/ml.The results from reagent packs 45675, 46353 and 46356 are in question.All qc results were within the acceptable range, however, the customer is concerned with the difference in results between the different reagent packs of the same lot number.The customer also ran 3 patient samples from a different hospital for troubleshooting purposes where the same difference in results was observed suggesting an issue with particular reagent packs for lot number 574764.The investigation is ongoing.
Additional Manufacturer Narrative
Calibration was acceptable for both lot numbers.Qc was acceptable, however, starting mid (b)(6) 2022 the values began to shift up and down outside of 3 standard deviations.The questionable low results from reagent packs (45675, 46353 and 46356) are consistent with storage/shipment issues.The low results are consistent with the reagent packs being subjected to incorrect temperatures or inverted positioning (or a combination of both) during shipment.From the information provided, a general reagent issue can be excluded.

• Brand Name: ELECSYS ANTI-TG
• Common Device Name: SYSTEM, TEST, THYROID AUTOANTIBODY
• 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: 15054434
• Report Number: 1823260-2022-02139
• Device Sequence Number: 4773271
• Product Code: JZO
• UDI-Device Identifier: 04015630929726
• UDI-Public: 04015630929726
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K053426
• 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): 08/18/2022

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: 10/31/2022
• Device Catalogue Number: 06368697190
• Device Lot Number: 574764
• 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: 06/25/2022
• Supplement Date Received by Manufacturer: 07/29/2022
• Initial Report FDA Received Date: 07/19/2022
• Supplement Report FDA Received Date: 08/18/2022
• 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