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

Catalog Number	08454345001
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter questioned high results for different patients and multiple parameters on a cobas e 801 analytical unit.Approximate discrepant high results were provided for 2 patient samples tested for elecsys ft4 iv (ft4 iv) and elecsys vitamin d total iii (vitamin d total iii).Patient 1: for ft4 iv the approximate results were 40 pmol/l and 20 pmol/l.For vitamin d total iii the approximate results were 440 ng/ml and 100 ng/ml.Patient 2: for ft4 iv the approximate results were 60 pmol/l and 20 pmol/l.
Additional Manufacturer Narrative
The vitamin d total iii reagent lot number was 71889401 with an expiration date of 29-feb-2024.The ft4 iv reagent lot number was 72497401 with an expiration date of 31-may-2024.On 11-nov-2023 a field service engineer (fse) visited the customer site but did not identify any issues.An fse returned to the customer site and replaced the pinch valves and a bent sipper nozzle.Qc was acceptable.The investigation is ongoing.
Additional Manufacturer Narrative
Data was provided for additional patient samples.Discrepant results were identified for 18 patient samples (patients 3 - 20) tested for elecsys troponin t hs (troponin t hs), vitamin d total iii, ft4 iv, and elecsys folate iii (folate iii).Patient 3 initial troponin t hs result was 92 ng/l.The repeat result was 195 ng/l.Patient 4 initial troponin t hs result was 23 ng/l.The repeat result was 58.4 ng/l.Patient 5 initial vitamin d total iii result was 166 nmol/l.The repeat result was 29.3 nmol/l.Patient 6 initial ft4 iv result was 23.9 pmol/l.The repeat result was 10.1 pmol/l.Patient 7 initial vitamin d total iii result was 221 nmol/l.The repeat result was 49.4 nmol/l.Patient 8 initial vitamin d total iii result was 486 nmol/l.The repeat result was 107 nmol/l.The initial ft4 iv result was 27.6 pmol/l.The repeat result was 11.5 pmol/l.Patient 9 initial ft4 iv result was 40.6 pmol/l.The repeat result was 17.5 pmol/l.The initial vitamin d total iii result was 161 nmol/l.The repeat result was 25.4 nmol/l.Patient 10 initial vitamin d total iii result was 256 nmol/l.The repeat result was 70.6 nmol/l.Patient 11 initial vitamin d total iii result was 234 nmol/l.The repeat result was 65.2 nmol/l.Patient 12 initial ft4 iv result was 64.8 pmol/l.The repeat result was 22.1 pmol/l.Patient 13 initial vitamin d total iii result was 274 nmol/l.The repeat result was 79.5 nmol/l.The initial folate iii result was 39 nmol/l.The repeat result was 17 nmol/l.Patient 14 initial vitamin d total iii result was 286 nmol/l.The repeat result was 88.3 nmol/l.Patient 15 initial folate iii result was 80 nmol/l.The repeat result was 35.5 nmol/l.The initial vitamin d total iii result was 251 nmol/l.The repeat result was 63.6 nmol/l.Patient 16 initial vitamin d total iii result was 239 nmol/l.The repeat result was 61.4 nmol/l.Patient 17 initial ft4 iv result was 41.5 pmol/l.The repeat result was 18.6 pmol/l.The initial vitamin d total iii result was 266 nmol/l.The repeat result was 74.1 nmol/l.Patient 18 initial ft4 iv result was 45.2 pmol/l.The repeat result was 20.2 pmol/l.The initial vitamin d total iii result was 181 nmol/l.The repeat result was 33.8 nmol/l.Patient 19 initial folate iii result was 24 nmol/l.The repeat result was 11.2 nmol/l.The initial ft4 iv result was 36.1 pmol/l.The repeat result was 14.8 pmol/l.The initial vitamin d total iii result was 261 nmol/l.The repeat result was 78.6 nmol/l.Patient 20 initial folate iii result was 23 nmol/l.The repeat result was 8.09 nmol/l.The initial vitamin d total iii result was 257 nmol/l.The repeat result was 69.3 nmol/l.Repeat testing was performed on (b)(6) 2023.The folate iii reagent lot number was 752739 with an expiration date of 31-jul-2025.The troponin t hs reagent lot number was 688155 with an expiration date of 30-apr-2024.
Additional Manufacturer Narrative
Several sample clot, foam, and pipetting alarms were observed on the alarm trace data.These alarms suggest a pre-analytical issue and correspond to the event.The investigation determined the event was due to a pre-analytical handling issue.

• 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: 18230633
• Report Number: 1823260-2023-03788
• Device Sequence Number: 6203112
• Product Code: JJE
• UDI-Device Identifier: 07613336158456
• UDI-Public: 07613336158456
• Combination Product (Y/N): Y
• Initial Reporter Country: NL
• 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,Followup
• Report Date (Section B): 02/01/2024

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: 11/13/2023
• Supplement Date Received by Manufacturer: 12/18/2023; 01/31/2024
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 01/11/2024; 02/01/2024
• 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