MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS E 601 MODULE; IMMUNOCHEMISTRY ANALYZER

Model Number E601

Device Problems Low Test Results (2458); Low Readings (2460); Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/24/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

The initial reporter complained of questionable results for an unknown number of patients tested with the elecsys troponin t hs stat reagent (tnt) on a cobas 6000 e601 module with serial number (b)(6).The reporter stated that on (b)(6) 2023 they calibrated the reagent; they stated that the calibration data was out of range but that the analyzer did not generate an alarm.They also stated that 1 level of control was in range, but they did not provide results for other control levels.They alleged that on (b)(6) 2023, all patients tested for tnt had a result of 3 ng/l.On (b)(6) 2023 the emergency department complained that all patients were receiving results of 3 ng/l and the results did not match the patients' clinical pictures.On (b)(6)2023 the laboratory recalibrated the reagent with new calibration material and ran controls with new control material.All qc values were acceptable.The reporter was able to provide 2 examples of questionable results from tests run on (b)(6)2023 on 2 patient samples: sample 1: initial tnt = 3 ng/l.The repeat tnt from (b)(6) 2023 was 27 ng/l.Sample 2: initial tnt = 3 ng/l.The repeat tnt from (b)(6) 2023 was 50 ng/l.

Manufacturer Narrative

The troponin t hs stat reagent lot number was 68812403 with an expiration date of 31-may-2024.The suspect medical device was updated.Relevant fields of sections d and g were updated.The investigation determined the customer performs calibration on their assays infrequently.The field service engineer (fse) replaced the measuring cells as they were due for replacement.The customer had no further issues following the service visit.

• Brand Name: COBAS E 601 MODULE
• Type of Device: IMMUNOCHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; na; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16932065
• MDR Text Key: 315425928
• Report Number: 1823260-2023-01637
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 04015630924714
• UDI-Public: 04015630924714
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E601
• Device Catalogue Number: 04745922001
• Device Lot Number: 68812403
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1