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 Consequences Or Impact To Patient (2199)
Date of Event	08/01/2016
Type of Reportable Event	Malfunction
Event or Problem Description
The customer stated that they received erroneous results for an unspecified number of samples from the same patient tested for the elecsys afp assay on a cobas 6000 e 601 module.The specific date of the event is not known.The customer stated that over a two year period, multiple samples from the patient recovered high afp results ranging between 761 and 1028 ng/ml when tested with multiple lots of the roche assay.When tested with the abbott and beckman coulter assays, the patient also had high values.The wako and siemens immulite platforms, however, yielded results from the patient which were within their respective normal reference ranges.The customer does not know which values are correct, but believes the high values to be in error.The customer suspects that samples from the patient contain an interferent to a component of the roche afp assay.The patient was not taking high levels of biotin.The customer provided data for two specific samples from the patient.No specific testing dates were provided for the two samples.The customer stated that the patient was last tested 2 to 3 months prior to (b)(6) 2018.The first sample resulted as 761 ng/ml when tested on the e601 analyzer.The value was reported outside of the laboratory and questioned by the doctor.The sample was sent to another laboratory for confirmation testing on the siemens immulite analyzer and the result was 3.42 ng/ml, which was within the normal range of that assay.The customer then sent the patient sample to other laboratories for testing on additional platforms.The sample resulted with values of 1.2 ng/ml and 3.2 ng/ml when tested on the wako platform.When tested on an abbott system, the sample recovered 802 ng/ml, which is considered high.The sample also recovered a high value of 1162 ng/ml when tested on the beckman platform.The first sample was also aliquoted and the customer ran a dilution series on the customer's e601 analyzer using this aliquot.The sample was tested without dilution, resulting as 778.4 ng/ml.A 1:1 dilution yielded a result of 355.9 ng/ml.A 1:2 dilution of the sample yielded a result of 214.2 ng/ml.A 1:4 dilution of the sample yielded a result of 124.4 ng/ml.A 1:9 dilution of the sample yielded a result of 58.41 ng/ml.A 1:1 dilution of the sample with mouse serum yielded a result of 337.1.A second sample from the patient resulted as 938 ng/ml when tested on the e601 analyzer.The sample was treated with a heterophilic antibody blocking tube from scantibodies and then tested on the e601 analyzer, resulting with a value of 970 ng/ml.The patient was not adversely affected.The serial number of the e601 analyzer is (b)(4).
Additional Manufacturer Narrative
A sample was sent to the manufacturer for investigation.The experiments did not show evidence for an abnormal result cause by interference in the elecsys assay.The investigations confirm the customer¿s afp results on cobas e601 the investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS AFP ASSAY
• Common Device Name: KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7822221
• Report Number: 1823260-2018-02897
• Device Sequence Number: 11140651
• Product Code: LOJ
• UDI-Device Identifier: 04015630920716
• UDI-Public: 4015630920716
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K981282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2018

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: Health Professional
• Device Catalogue Number: 04481798190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/08/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 08/28/2018
• Supplement Report FDA Received Date: 10/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OMEPRAZOLE; TENOFOVIR
• Patient Age: 50 YR
• Patient Weight: 59