MAUDE Adverse Event Report: ROCHE DIAGNOSTICS HEMOGLOBIN A1C GEN.2; ASSAY, GLYCOSYLATED HEMOGLOBIN

Catalog Number 05401640190

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2016

Event Type  malfunction  

Manufacturer Narrative

It was asked, but it is not known in which country this event occurred.

Event Description

The customer reported that they received questionable results for approximately six patient samples tested for tina-quant hemoglobin a1c gen.2 (hba1c) on a c111 analyzer.The customer loaded a new hba1c reagent kit on the analyzer and initially tested the patient samples.Patient values were said to be either too high or too low.The samples were repeated after the reagent kit was replaced and calibrated.Of the six patient samples, two were found to have erroneous hba1c results.It was stated that none of the erroneous results were reported to the patient.It was not clear if any erroneous results were reported outside of the laboratory.A clarification has been requested.The first sample initially resulted as 4.8%.After the reagent kit was replaced, the sample was repeated, resulting as 6.69%.The second sample initially resulted as 7.0%.The sample was repeated outside of the laboratory on a different analyzer, resulting as 9.0%.After the reagent kit was replaced on the original analyzer, the sample was repeated again, resulting as 8.9%.The patients were not adversely affected.The c111 analyzer serial number was (b)(4).It was stated that the customer was not running quality controls and that they were doing weekly interlab comparisons with hba1c hplc method.The customer stated that they did not have any further issues after replacing the reagent cassette.

Manufacturer Narrative

A specific root cause could not be determined based on the provided information.Additional information required for the investigation was requested, but not provided.A reagent issue can be excluded.

• Brand Name: HEMOGLOBIN A1C GEN.2
• Type of Device: ASSAY, GLYCOSYLATED HEMOGLOBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• 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: 5430224
• MDR Text Key: 38015649
• Report Number: 1823260-2016-00138
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• PMA/PMN Number: K072714
• 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: 03/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: 05401640190
• Device Lot Number: 610611-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2016
• Initial Date FDA Received: 02/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/16/2016
• 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