MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FERRITIN; RADIOIMMUNOASSAY (TWO-SITE SOLID PHASE), FERRITIN

Catalog Number 03737551160

Device Problems High Test Results (2457); Non Reproducible Results (4029)

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

Event Date 09/30/2021

Event Type  malfunction  

Manufacturer Narrative

The sample was requested for investigation.

Event Description

The initial reporter received a questionable elecsys ferritin result for one patient sample with the cobas e411 immunoassay analyzer serial number (b)(4).The initial result was 25.8 ng/ml.This result was reported outside the laboratory and questioned as it did not match medical history.On (b)(4) 2021, a new sample was tested with a result of 18.16 ng/ml.On (b)(4) 2021, the sample was sent to an external laboratory and tested with an architect with a result of 7.1 ng/ml.On (b)(4) 2021, the sample was repeated on another e411 at the customer site with a result of 16.78 ng/ml.

Manufacturer Narrative

The customer's calibration and qc results were ok.There was no indication of a reagent issue.The sample was received for investigation and was measured on cobas pro c 503 and e 411.Results of sample measurements: ferritin (e 411) ¿ 18.13 g/l (expected values as per method sheet: 13-150 ng/ml); ferr 4 (c503) ¿ 16.3 g/l (expected values as per method sheet: 15-150 ng/ml).The customer's ferritin result could be confirmed on both analyzers.The customer sample was sent to an external lab for measurement with another competitor method (centaur).Result: 14 ng/ml.Expected values as per competitor database are 10-291 ng/ml (females, 95th percentile range).The obtained result is comparable to the elecsys results and is on the lower end of the respective expected values.To the mathematical differences between the values generated with different assays, it needs to be taken into account that assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used and, differences in reference materials/methods, and the standardization methodology used.No product problem was detected.

• Brand Name: ELECSYS FERRITIN
• Type of Device: RADIOIMMUNOASSAY (TWO-SITE SOLID PHASE), FERRITIN
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 12714786
• MDR Text Key: 279311527
• Report Number: 1823260-2021-03156
• Device Sequence Number: 1
• Product Code: JMG
• UDI-Device Identifier: 04015630938940
• UDI-Public: 04015630938940
• Combination Product (y/n): N
• Reporter Country Code: PM
• 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
• Report Date: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 03737551160
• Device Lot Number: 53055105
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2021
• 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
• Patient Age: 36 YR
• Patient Sex: Female