MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TROPONIN T STAT ASSAY; IMMUNOASSAY METHOD, TROPONIN SUBUNIT

Model Number	TNT G5 STAT
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) found that the issue was related to a bad calibration that was accepted by the technician causing the high results.The customer re-calibrated and repeated qc with acceptable results.The fse performed precision testing with acceptable results.After re-calibrating the customer ran samples tested for troponin t stat in duplicate.After the first 10 patient samples returned with matching results, patient samples were run as normal.No other diagnostic issues were noted after re-calibration was performed.The investigation is ongoing.
Event or Problem Description
The initial reporter complained of high results for multiple patient samples tested for elecsys troponin t stat assay (troponin t stat) on a cobas 6000 e 601 module.The customer stated she had a doctor call about a result.The customer provided discrepant results for 2 patient samples.Patient 1 initial result was 28 ng/l.The repeat on a different e601 module was 14 ng/l.Patient 2 initial result was 20 ng/l.The repeat on a different e601 module was 6 ng/l.The initial results were reported outside of the laboratory.The repeat results were believed to be correct.The e601 module serial number was (b)(4).
Additional Manufacturer Narrative
Calibration was last performed on (b)(6) 2022.The calibration trace data showed a drop in calibration signals on 22-sep-2022.The fse indicated a bad calibration was performed prior to the event.Qc results were initially low but were within range when repeated.The customer used a centrifugation time of 10 minutes at 10000 revolutions per minute (rpm).Based on the sample tubes used, this centrifugation speed may be too low.The customer's actions of re-calibrating resolved the issue.

• Brand Name: ELECSYS TROPONIN T STAT ASSAY
• Common Device Name: IMMUNOASSAY METHOD, TROPONIN SUBUNIT
• 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: 15668544
• Report Number: 1823260-2022-03345
• Device Sequence Number: 6462499
• Product Code: MMI
• UDI-Device Identifier: 04015630942695
• UDI-Public: 04015630942695
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2022

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: 10/31/2023
• Device Model Number: TNT G5 STAT
• Device Catalogue Number: 07398000160
• Device Lot Number: 63006300
• 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: 10/04/2022
• Supplement Date Received by Manufacturer: 12/09/2022
• Initial Report FDA Received Date: 10/25/2022
• Supplement Report FDA Received Date: 12/27/2022
• 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 Age: 80 YR
• Patient Sex: Female
• Patient Weight: 70 KG