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

Catalog Number 08454345001

Device Problem High Readings (2459)

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

Event Date 09/21/2023

Event Type  malfunction  

Manufacturer Narrative

The reagent lot number and expiration date were requested but were not provided.The investigation is ongoing.

Event Description

There was an allegation of questionable estradiol results for quality control material and patient samples from the cobas e 801 analytical unit.Sample 1 initial result was 40.70 pmol/l and the repeat results were 4271 pmol/l and 46.60 pmol/l.On 03-oct-2023, sample 2 initial result was 166 pmol/l and the repeat results were 2026 pmol/l and 171 pmol/l.No information was provided to determine if the questionable result was reported outside of the laboratory.

Manufacturer Narrative

The field service engineer cleaned the unit and replaced parts.The customer provided additional questionable results: on 06-oct-2023, sample 3 initial result 115 pmol/l.The repeat results were 19 pmol/l and <19 pmol/l.On (b)(6) 2023, sample 4 initial result was 943 pmol/l and the repeat results were 505 pmol/l and 505 pmol/l.On (b)(6) 2023, sample 5 initial result was 300 pmol/l and the repeat results were 672 pmol/l, 282 pmol/l, and 288 pmol/l.On (b)(6) 2023, sample 6 initial result was 358 pmol/l and the repeat results were 177 pmol/l and 173 pmol/l.On (b)(6) 2023, sample 7 initial result was 2359 pmol/l and the repeat results were 473 pmol/l and 470 pmol/l.The investigation is ongoing.

Manufacturer Narrative

The investigation determined the root cause of the false high results was environmental contamination via the laboratory's air conditioning system and laboratory personnel using hrt (hormone replacement therapy).

• 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; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17908074
• MDR Text Key: 325316003
• Report Number: 1823260-2023-03250
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 07613336158456
• UDI-Public: 07613336158456
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08454345001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1