MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-HAV II; HEPATITIS A TEST

Catalog Number 08086664190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/14/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter complained of (b)(6) results for 22 patient samples tested for elecsys (b)(6) on a cobas e801 module compared to the elecsys (b)(6) assay and the abbott architect method.The customer provided actual results for only 3 patient samples and only the results for elecsys (b)(6) and elecsys (b)(6).The elecsys (b)(6) test is quantitative with a cut-off = 20 iu/l (> 20 iu/l is (b)(6)).The elecsys (b)(6) test is qualitative with a cut-off = 1 coi (< 1 is (b)(6)).Patient 1 (b)(6) result was 15.3 iu/l ((b)(6)).The (b)(6) result was 0.851 coi ((b)(6)).The result from the abbott method was (b)(6).The actual result was not provided.Patient 2 (b)(6) result was 18.3 iu/l ((b)(6)).The (b)(6) result was 0.903 coi ((b)(6)).The result from the abbott method was (b)(6).The actual result was not provided.Patient 3 (b)(6) result was 17.2 iu/l ((b)(6)).The (b)(6) result was 0.703 coi ((b)(6)).The result from the abbott method was (b)(6).The actual result was not provided.The reporter did not provide any actual results for the additional 19 patient samples.The reporter stated the results from the e801 module were "(b)(6)" and the results from the abbott method were "(b)(6)." it is not clear if the data complained about was for diagnostic purposes.No questionable results were reported outside of the laboratory.The e801 module serial number was (b)(4).

Manufacturer Narrative

The customer sent 27 patient samples in for investigation.The samples were tested for anti-hav ii and anti-hav on a cobas e801 module.The elecsys anti-hav test is quantitative with a cut-off = 20 iu/l (= 20 iu/l is positive).The elecsys anti-hav ii test is qualitative with a cut-off = 1 coi (= 1 is positive).The customer's results for anti-hav ii results were confirmed for 5 patient samples: sample (b)(6): anti-hav ii result = 0.778 (positive) anti-hav = 16.7 (negative).Sample (b)(6): anti-hav ii result = 0.729 (positive) anti-hav = 18.9 (negative).Sample (b)(6) anti-hav ii result = 0.956 (positive) anti-hav = 18.3 (negative).Sample (b)(6): anti-hav ii result = 0.825 (positive) anti-hav = 18.2 (negative).Sample (b)(6): anti-hav ii result = 0.945 (positive) anti-hav = 9.23 (negative).The investigation is ongoing.

Manufacturer Narrative

The samples were investigated further for interfering substances.For all samples, an interference was not identified.The samples may contain low concentrations of analytes.The anti-hav ii assay was designed to have a higher sensitivity than the anti-hav assay.The investigation did not identify a product problem.

• Brand Name: ELECSYS ANTI-HAV II
• Type of Device: HEPATITIS A TEST
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9820177
• MDR Text Key: 220577911
• Report Number: 1823260-2020-00705
• Device Sequence Number: 1
• Product Code: LOL
• Combination Product (y/n): N
• PMA/PMN Number: K190428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08086664190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1