MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS HBSAG CONFIRMATORY TEST; TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)

Catalog Number 11820648122

Device Problems Use of Incorrect Control/Treatment Settings (1126); False Negative Result (1225)

Patient Problem Misdiagnosis (2159)

Event Date 06/23/2015

Event Type  malfunction  

Manufacturer Narrative

Investigations have determined that the customer was using the incorrect calculation.Using the old calculation algorithm, the result was indeterminate.Based on the instructions for use, the sample should be repeated.Should the result remain indeterminate, a follow up sample should be examined.

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer reported that they were using an old algorithm for interpreting a result value for one patient sample tested with the (b)(6) confirmatory test.Labeling instructs the customer to use a new algorithm when interpreting results for lots numbers 175264 and onward.The customer was using a lot number which was greater than lot number 175264.The sample initially resulted as (b)(6).The sample was repeated and resulted as (b)(6).Because the sample was repeatedly (b)(6), the sample was then tested using the (b)(6) confirmatory test.As calculated by the customer, the result of the (b)(6) confirmatory test was (b)(6).Although the customer stated they were using the old algorithm, it is unclear from the information provided as to what algorithm they used.More information has been requested.The negative confirmation result was reported outside of the laboratory.If using the new algorithm, the confirmation result would have been (b)(6).It was asked, but it is not known if the patient was adversely affected.The sample was tested on an e601 analyzer.The serial number of the analyzer was asked for, but not provided.

• Brand Name: ELECSYS HBSAG CONFIRMATORY TEST
• Type of Device: TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 5380130
• MDR Text Key: 37009171
• Report Number: 1823260-2016-00057
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: P990012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11820648122
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2015
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1