MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 E 601 MODULE; IMMUNOCHEMISTRY ANALYZER

Model Number	E601
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys hcg v2 and v3 test system results from 1 patient on a cobas 6000 e 601 module.On (b)(6) 2022, the initial hcg v2 result was 1.0 miu/ml.The result was reported outside of the laboratory.The patient took a pregnancy test at home that was positive and was advised to have another sample collected.The new sample gave a result of over 800 miu/ml.On (b)(6) 2022, an aliquot of the original sample was repeated and the result was 79.25 miu/ml.The sample was repeated using a new hcg v3 reagent.The original tube was re-centrifuged and also repeated and the result was 71 miu/ml.The repeat result of 79.25 miu/ml was deemed correct.The hcg v2 reagent lot is 56666900 and the expiration date is 31-jan-2023.The hcg v3 reagent lot is 62829300 and the expiration date is 31-oct-2023.
Additional Manufacturer Narrative
Calibration was last performed on 07-nov-2022 and showed signals slightly lower than expected.Qc recovery was within range.The alarm trace did not contain a conspicuous event.The field service engineer found that the measuring cells were due for replacement and replaced them.An instrument check and blank cell calibration were performed successfully.The service maintenance actions performed by the fse resolved the issue.No further issues were reported after the service visit.

• Brand Name: COBAS 6000 E 601 MODULE
• Common Device Name: 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: 15900427
• Report Number: 1823260-2022-03839
• Device Sequence Number: 12074858
• Product Code: JJE
• UDI-Device Identifier: 04015630919383
• UDI-Public: 04015630919383
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K060373
• 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): 12/28/2022

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 Model Number: E601
• Device Catalogue Number: 05860652001
• 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: 11/09/2022
• Supplement Date Received by Manufacturer: 12/10/2022
• Initial Report FDA Received Date: 12/01/2022
• Supplement Report FDA Received Date: 12/28/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ENDOMETRIN; ESTROGEN PATCH
• Patient Age: 45 YR
• Patient Sex: Female