MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS E 801 ANALYTICAL UNIT; IMMUNOCHEMISTRY ANALYZER

Catalog Number	08454345001
Medical Device Problem Codes	Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The vit b12 reagent lot number is 740845.The expiration date was requested but not provided.The ft4 iv reagent lot number is 724974.The expiration date was requested but not provided.The vit d, probnp, tsh, ferritin and folate reagent lot numbers and their expiration dates were requested but not provided.The field service engineer (fse) inspected the analyzer and performed a multi-point check to confirm the analyzer's functionality; the results were acceptable.He verified the probe adjustments, external washing of probes, and mixer paddle.He also checked the main pump pressure which was at 65 kpa.He also checked the gear pump head (gph) pressure which was at 290 kpa and adjusted it to up to 320 kpa.He performed internal qcs with successful results.The investigation reviewed the last calibration performed on 21-nov-2023; the results were within specifications.The investigation reviewed the alarm trace; one "sample short"alarm on 22-nov-2023 at 3:48 pm and one "procell short" alarm on 22-nov-2023 at 4:09 pm.The investigation reviewed the qc data from the digital laboratory management software; the data showed a strong fluctuation between +/- 3 standard deviations (sd).The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys vitamin b12 ii (vitamin b12 ii), elecsys vitamin d, elecsys tsh, elecsys ft4 iv assay, elecsys probnp, elecsys ferritin and elecsys folate results from seven patient samples tested on the cobas e 801 analytical unit.The initial results were reported outside of the laboratory.Sample (b)(6).The initial vit b12 result was 374.The repeat result was 493.Sample (b)(6).The initial vit b12 result was <100 (not reported outside the laboratory).The repeat result was 268.On 22-nov-2023, the initial ferritin result was 3.77.On 23-nov-2023, the repeat result was 17.On 22-nov-2023, the initial vit d result was 42.9.On 23-nov-2023, the repeat result was 78.9.On 22-nov-2023, the initial tsh result was 1.04.On 23-nov-2023, the repeat result was 1.53 (the reference ranges were not provided).Sample (b)(6) on 22-nov-2023, the initial vit d result was 46.9.On 23-nov-2023, the repeat result was 79.2.Sample (b)(6) on 22-nov-2023, the initial pro-bnp result was 89.6.On 23-nov-2023, the repeat result was 536.Sample (b)(6) on 22-nov-2023, the initial pro-bnp result was 66.On 23-nov-2023, the repeat result was 1228.On 22-nov-2023, the initial ft4 result was 1.59.On 23-nov-2023, the repeat result was 13.2 (the reference range was not provided).Sample (b)(6) on 22-nov-2023, the initial ferritin result was 9.91.On 23-nov-2023, the repeat result was 147.On 22-nov-2023, the initial folate result was 1.49.On 23-nov-2023, the repeat result was 6.65.On 22-nov-2023, the initial vit b12 result was <100.On 23-nov-2023, the repeat result was 512.Sample (b)(6) on 27-nov-2023, new discrepant results were reported.The initial ft4 result was 27.The repeat result was 20 (the reference range was not provided).The reporter amended the initially reported results.The units of measurement were not provided.
Additional Manufacturer Narrative
The field service engineer (fse) performed an instrument check with successful results.The investigation determined that the event was consistent with a partial/ temporary blockage and clogging of the sample probe (sample short alarm in the alarm trace shortly before the questionable results were obtained).Product labeling states "daily maintenance of the e 801 module - cleaning probes and nozzles of the e 801 module - to ensure that the instrument measures accurately, you must clean the sample probe, reagent probes, the nozzles of the pre-wash area, and the ecl sipper nozzle." after service, no further issues were reported by the customer.

• Brand Name: COBAS E 801 ANALYTICAL UNIT
• 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; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18347192
• Report Number: 1823260-2023-04079
• Device Sequence Number: 5600731
• Product Code: JJE
• UDI-Device Identifier: 07613336158456
• UDI-Public: 07613336158456
• Combination Product (Y/N): Y
• Initial Reporter Country: EI
• PMA/510(K) Number: K060373
• 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): 01/17/2024

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 Catalogue Number: 08454345001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/23/2023
• Supplement Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 01/17/2024
• 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