MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ASSAYTIP/ASSAYCUP TRAY; EQUIPMENT, LABORATORY, GENERAL PURPOSE

Catalog Number 05694302001

Device Problem Incorrect Measurement (1383)

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

Event Date 01/08/2024

Event Type  malfunction  

Event Description

We received an allegation about discrepant results for 1 patient's serum/plasma sample tested with acth assay and 1 patient's serum/plasma sample tested with fsh and prl assays and 1 patient's serum/plasma sample tested with t4 assay on a cobas e801 immunoassay analyzer when compared to a cobas pro analyzer.Sample 1 (patient 1): acth: initial result: 89.1 pg/ml.1st repeat result: 7.52 pg/ml.2nd repeat result: 78.8 pg/ml.Sample 2 (patient 2): fsh: initial result: 8.13 miu/ml.Repeat result: 0.305 miu/ml.Prl: initial result: 12.90 ng/ml.Repeat result: 0.517 ng/ml.Sample 3 (patient 3): t4: initial result: 59.30 mmol/l.1st repeat result: 7.22 mmol/l.2nd repeat result: 57.50 mmol/l.3rd repeat result: 58.80 mmol/l.No questionable results were reported outside the laboratory.The customer considered the initial results to be correct.

Manufacturer Narrative

The acth reagent lot number was 705134.The fsh reagent lot number was 701029.The prl reagent lot number was 765079.The t4 reagent lot number was 741920.The expiration dates of act, fsh, prl, and t4 reagents were not provided.Qc was within the assigned ranges on the day of the event.The measuring cell was last exchanged on (b)(6)2023.The field service engineer (fse) found that the sample probe was misaligned.He adjusted the sample probe, the sample probe arm, the reagent probes, and the sipper probes.He also checked and adjusted the magnet drive on the measuring cell.The fse performed probe decontamination, checked the prewash functionality, and exchanged the measuring cells.The fse did a performance check and the instrument was performing within specifications.The tips/cups were changed after the service visit.No further issues were reported afterward.The investigation is ongoing.

Manufacturer Narrative

The investigation is ongoing.

Manufacturer Narrative

The root cause of the issue was related to defective assay tips.The tip lot used is covered by a roche initiated recall.Customer was informed to stop using the affected tips.The affected tip lot was not distributed in the united states.

• Brand Name: ASSAYTIP/ASSAYCUP TRAY
• Type of Device: EQUIPMENT, LABORATORY, GENERAL PURPOSE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 18608361
• MDR Text Key: 334650846
• Report Number: 1823260-2024-00271
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): Y
• Reporter Country Code: GR
• PMA/PMN Number: EXEMPT
• 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: 05/14/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05694302001
• Device Lot Number: 23274776
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2024
• Initial Date FDA Received: 01/30/2024
• Supplement Dates Manufacturer Received: 02/01/2024; 04/30/2024
• Supplement Dates FDA Received: 02/23/2024; 05/14/2024
• 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