MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS PRO SBL E 801; IMMUNOCHEMISTRY ANALYZER

Model Number	E801
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) adjusted the sample probe vertically and horizontally.The probe was internally cleaned and the foam detection camera was turned on.There were no other issues noted.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys ft4 assay, probnp g2 elecsys e2g v2, elecsys ferritin, folate, elecsys tsh assay and elecsys vitamin b12 immunoassay results for two patient samples tested on the cobas pro sbl e 801.For sample 2063033611, the initial ft4 result was reported to the physician.The physician did not believe the result prompting the rerun of several assays.Discrepant results were observed for ft4 and probnp.On (b)(6) 2022, sample 1's initial ft4 result was 1.820 pmol/l with a data flag.The repeat result was 40.9 pmol/l.The initial probnp result was <1 pmol/l with a data flag.The repeat result was 67 pmol/l.On (b)(6) 2022, sample 2071221711's initial ferritin result was 1.640 ug/l with a data flag.The repeat result was 114 ug/l.The initial folate result was <2.72 nmol/l with a data flag.The repeat result was 45.100 nmol/l.The initial tsh result was <0.1 miu/l with a data flag.The repeat result was 5.000 miu/l.The initial vitamin b12 result was <73.8 pmol/l with a data flag.The repeat result was 366 pmol/l.The repeat results were deemed correct.The ft4 reagent lot number is 60647801 with an expiration date of 30-nov-2022.The probnp reagent lot number is 60018601 with an expiration date of 31-may-2022.The ferritin, folate, tsh and vitamin b12 reagent lot numbers and their expiration dates were requested but not provided.
Additional Manufacturer Narrative
The calibration and qc were within their specified ranges.A general reagent issue can be excluded.The investigation determined that the event was consistent with incorrect pipetting due to the incorrectly adjusted sample pipettor.After service, no further issues were reported by the customer.  the investigation determined the service actions resolved the issue. .

• Brand Name: COBAS PRO SBL E 801
• 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: 15133328
• Report Number: 1823260-2022-02231
• Device Sequence Number: 17762785
• Product Code: JJE
• UDI-Device Identifier: 07613336179918
• UDI-Public: 07613336179918
• Combination Product (Y/N): N
• 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): N
• 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): 09/22/2022

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: E801
• Device Catalogue Number: 09211888001
• 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: 07/04/2022
• Supplement Date Received by Manufacturer: 08/30/2022
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 09/23/2022
• 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 Sex: Unknown