MAUDE Adverse Event Report: ROCHE DIAGNOSTICS IGA-2; IMMUNOGLOBULIN A

Catalog Number	08057885190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received questionable results for one patient sample tested with iga-2 tina-quant iga gen.2 on a cobas pro c 503 analyzer (serial number (b)(4)).A questionable value from the sample was reported outside of the laboratory.The sample values did not correspond to other laboratory findings of the patient and a high dose hook effect was suspected.The sample was initially tested twice and did not generate iga values, only data flags.The sample was repeated, resulting in a value of 0.167 g/l.The sample was diluted 1:3 by the analyzer and repeated, resulting in a value of 0.0758 g/l.The sample was repeated on (b)(6) 2022, resulting in a value of 0.77 g/l.The 0.77 g/l value was reported outside of the laboratory to medical personnel.Other laboratory findings of the patient include a total protein result of 128 g/l and an iga "m gradient" electrophoresis result (calculated iga) of 80 g/l.Immunofixation of the patient sample confirmed the presence of iga lambda.Refer to the attachment for electrophoresis and immunofixation results.Based on these findings, multiple myeloma type iga lambda of the patient is suspected.
Additional Manufacturer Narrative
Na.
Additional Manufacturer Narrative
Medwatch field d4, lot number has been updated.For the sample measurements of 0.167 g/l on 11-apr-2022 and 0.77 g/l on (b)(6) 2022, the customer is fairly confident these results were also measured with a programmed dilution on the analyzer.The patient sample was provided for investigation and the results obtained by the customer could be reproduced.The results showed a very high concentration of iga in the patient sample.A clear result could not be obtained as all values showed flags indicating the absorbance was higher than the technical limit of the assay.The cause of the incorrectly low measured results in customers lab without a flag is consistent with a handling error during the repeat measurement.Dilutions performed on the analyzer outside of the decreased mode have to be performed manually, as the default pre-dilution for the iga application is cancelled and an incorrect /invalid result is measured.Per product labeling: "to measure the sample with a specific dilution, choose the dilution from the drop-down list on the test key.A manual selection overwrites the preprogrammed dilution ratio indicated on menu > application > analytical parameters.If the test has a pre-programmed dilution ratio of 1:5, for example, and you select 1:2, the test is processed with a dilution ratio of 1:2." the product is working within specifications.

• Brand Name: IGA-2
• Common Device Name: IMMUNOGLOBULIN A
• 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: 14269793
• Report Number: 1823260-2022-01254
• Device Sequence Number: 5702937
• Product Code: CZP
• UDI-Device Identifier: 07613336121313
• UDI-Public: 07613336121313
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K040435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2022

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
• Operator of Device: Health Professional
• Device Catalogue Number: 08057885190
• Device Lot Number: 562161
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2022
• Supplement Date Received by Manufacturer: 05/03/2022
• Initial Report FDA Received Date: 05/03/2022
• Supplement Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Male