MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FERRITIN; FERRITIN IMMUNOLOGICAL TEST SYSTEM

Catalog Number 07027273190

Device Problems Device Damaged Prior to Use (2284); High Test Results (2457); High Readings (2459); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 08/22/2022

Event Type  malfunction  

Manufacturer Narrative

Only one qc (s4) was run for the reported reagent pack which gave questionable results.The result was between 2-3 sd.The customer did not realize that he performed the qc (s4) rerun and the qc (s2) on a different reagent pack.The customer noted "red beans" (most likely agglutinated microbeads) on the lids of the reagent pack in position 36.The investigation is ongoing.

Event Description

The initial reporter received questionable elecsys ferritin (ferritin) results for 57 patient samples tested on the cobas e 801 analytical unit with serial number (b)(4).The initial results were reported outside of the laboratory.On (b)(6) 2022, the patient samples were run using a particular reagent pack.On (b)(6) 2022, the patient samples were rerun using a new reagent pack with the same lot number.The repeat results were noted to be 30-40% lower than the initial results.The initial results were corrected.The reporter was able to provide one example of a discrepant result: the initial result was 18.00 ug/l.The repeat result was 10.00 ug/l.

Manufacturer Narrative

The customer provided the list containing the 56 other questionable results.Three discrepant results were noted.Sample 1 - the initial result was 1743 ug/l.The repeat result was 1081 ug/l.Sample 2 - the initial result was 1473 ug/l.The repeat result was 932 ug/l.Sample 3 - the initial result was 2075 ug/l.The repeat result was 1316 ug/l.

Manufacturer Narrative

The (b)(6) 2022 calibration of the complained reagent pack failed.There was no detailed calibration monitor provided to check what the calibration error was.There was no qc lot number or target values and ranges available for detailed assessment.It was reported that the qc with the complained reagent pack was between 2-3 sd.The qc of the complained reagent pack was consistently higher compared to other reagent packs from the same lot on all days (b)(6) 2022, (b)(6) 2022, (b)(6) 2022 (on average +36% for the high level and +38% for the low level).The alarm trace had a calibration error alarm at 09:33 on (b)(6) 2022 for the ferritin calibration.The alarm trace had a few sample quality alarms (sample short, sample clot detection) available during the days.The provided images from the complained reagent pack show clearly agglutinated microparticles (beads) in the lid.The investigation determined that the calibration failed and qc was high with the affected reagent pack.The reagent pack had visible microparticles (beads) in the lid, which likely contributed to the impaired performance of the reagent pack.The investigation determined that the issue was consistent with the presence of agglutinated beads in the reagent pack.The presence of the said beads may be due to sub-optimal reagent kit storage or transportation, e.G.Kit turned upside down.It is not clear when and where this happened (during shipment or at the customer site).In general, the reagents are transported in an upright position.A general reagent problem can be excluded because another reagent pack of the same lot performed according to expectations.The issue was resolved by the use of another reagent pack of the same lot.

• Brand Name: ELECSYS FERRITIN
• Type of Device: FERRITIN IMMUNOLOGICAL TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15563701
• MDR Text Key: 306848186
• Report Number: 1823260-2022-03090
• Device Sequence Number: 1
• Product Code: JMG
• UDI-Device Identifier: 04015630939688
• UDI-Public: 04015630939688
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K971833
• 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: 01/04/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 07027273190
• Device Lot Number: 602731
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2022
• Initial Date FDA Received: 10/07/2022
• Supplement Dates Manufacturer Received: 10/11/2022; 12/07/2022
• Supplement Dates FDA Received: 11/04/2022; 01/04/2023
• 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