MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS AFP ASSAY; KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER

Catalog Number	04481798190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Afp assays from different vendors can produce different results.Afp values determined on patient samples by different testing procedures cannot be directly compared with one another and could be the cause of erroneous medical interpretations.This information is included in the package insert for the assay.Based on calibration and qc data a general reagent issue could be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.D.4 lot number and expiration date were updated.
Additional Manufacturer Narrative
The afp reagent lot number was 298297 with an expiration date of 28-feb-2019.The repeat afp result was 9.4 ng/ml with the lumipulse method.The initial investigation determined that the customer's calibration and qc were acceptable.
Event or Problem Description
The customer complained of discrepant elecsys afp assay results for two samples from one patient on a cobas 8000 e 602 module, serial number (b)(6).For sample 1, the initial afp result was 9.6 ng/ml.The result was 3.1 ng/ml with the wako method.The results were reported outside of the laboratory.The physician questioned the results.On (b)(6) 2018, a new sample was collected and the initial afp result was 7.7 ng/ml.The afp result was 2.2 ng/ml with the wako method.There was no allegation of an adverse event.The sample that was collected on (b)(6) 2018 was provided for investigation.The afp results were 8.93 ng/ml and 8.49 ng/ml from a cobas 6000 e 601 module.
Additional Manufacturer Narrative
This event occurred in jpn.

• Brand Name: ELECSYS AFP ASSAY
• Common Device Name: KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague rd.; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; mannheim(baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague rd.; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 7719092
• Report Number: 1823260-2018-02313
• Device Sequence Number: 3491622
• Product Code: LOJ
• UDI-Device Identifier: 04015630920716
• UDI-Public: 4015630920716
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K981282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Unknown
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/07/2018

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: Other
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 04481798190
• Device Lot Number: 298297
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 06/28/2018; 06/28/2018
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 07/25/2018; 09/07/2018
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Male