MAUDE Adverse Event Report: ROCHE DIAGNOSTICS HBA1C II; ASSAY, GLYCOSYLATED HEMOGLOBIN

Catalog Number 04528123160

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/13/2015

Event Type  malfunction  

Manufacturer Narrative

Na.

Event Description

The customer received a questionable hemoglobin a1c result for one patient sample from an integra 800 analyzer.The serial number was either "(b)(4)" or "(b)(4)".Clarification was requested.The initial result was 3.5% and was reported outside the laboratory.The physician questioned the result and the same sample was repeated on (b)(6) 2015 on another integra 800 analyzer and the result was 6.4%.The customer also tested the same sample on an additional integra 800 analyzer and received an almost identical result.The customer could not provide the exact result, but his recollection was that it was 6.2%.The repeat result was believed to be correct.The patient was not adversely affected.The field service representative found there was an issue with the hba1c product.He performed photometer checks and instrument performance checks.Pipetting precision of the analyzer was working correctly.

Manufacturer Narrative

Based on the provided data, a specific root cause could not be determined.The most likely cause was a pre-analytical issue.

• Brand Name: HBA1C II
• Type of Device: ASSAY, GLYCOSYLATED HEMOGLOBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• 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: 5067718
• MDR Text Key: 25890116
• Report Number: 1823260-2015-04124
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 10/26/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Catalogue Number: 04528123160
• Device Lot Number: 60802001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/26/2015
• 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
• Patient Age: 055 YR