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

Model Number E801

Device Problems Unable to Obtain Readings (1516); Low Test Results (2458); Non Reproducible Results (4029)

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

Event Date 01/11/2023

Event Type  malfunction  

Manufacturer Narrative

The field service engineer determined a tear in a reagent probe tubing.The investigation is ongoing.

Event Description

The initial reporter stated they had quality control issues for multiple tests and received results above or below the measuring range for an unspecified number of patient samples tested with multiple elecsys assays on a cobas e 801 analytical unit.The field service engineer checked and repaired the analyzer and the samples were repeated on (b)(6) 2023.The customer provided an example of two patient samples, tested with the elecsys tsh and elecsys ft4 assays.Patient sample 1, tested with elecsys tsh: the sample initially resulted in a tsh value of < 0.007 uiu/ml, accompanied by a data flag.On (b)(6) 2023, the sample was repeated after the repair and resulted in a tsh value "between 2.0 - 4.0 uiu/ml".No specific value was provided.Patient sample 2, tested with elecsys ft4: the sample initially resulted in an ft4 value of > 7.77 ng/dl, accompanied by a data flag.On (b)(6) 2023, the sample was repeated after the repair and resulted in an ft4 value of 3.9 ng/dl.The customer further mentioned that elecsys ft3, vitamin d, vitamin b12, and folate also recovered above the measuring range initially and "repeated anywhere from 25-50% lower" on repeat after the repair.No specific values were provided."some" of the initial questionable results were reported outside of the laboratory and an amended report was issued.The tsh, ft4, ft3, vitamin d, vitamin b12 and folate reagent lots and expiration dates were requested but not provided.

Manufacturer Narrative

The field service engineer replaced the reagent tubing.The customer ran calibration and quality controls.No error or alarm was observed.The investigation determined the service actions performed resolved the issue.

• Brand Name: COBAS E 801 ANALYTICAL UNIT
• 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: 16327861
• MDR Text Key: 309509774
• Report Number: 1823260-2023-00411
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E801
• Device Catalogue Number: 08454345001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2023
• 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