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

Catalog Number 04528123190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/03/2016

Event Type  malfunction  

Event Description

The customer stated that they received questionable results for an unspecified number of patient samples tested for tina-quant hemoglobin a1c gen.2 (hba1c) on an integra 800 analyzer.The physician had questioned hba1c results for 3 patient samples.The customer was able to narrow down the issue to samples tested on (b)(6) 2016 between 18:17 and 20:08.The patient samples were repeated and 150 patient results were corrected.The customer stated that all paired sample results correlated closely later in the day on (b)(6) 2016 after daily maintenance had been performed.The customer provided an example of one patient sample that had an erroneous hba1c result that had been reported outside of the laboratory.The sample initially resulted as 8.0 % and this value was reported outside of the laboratory.The sample was repeated on (b)(6) 2016, resulting as 4.3 %.The repeat result was believed to be correct.The patient was not adversely affected.The integra 800 analyzer serial number was (b)(4).The field service representative determined that the issue may have been caused by the reagent pack that was in use.He performed a check test and this passed.All mechanical and operational checks passed successfully.

Manufacturer Narrative

A specific root cause could not be determined based on the provided information.A review of the analyzer alarm trace showed "insufficient sample" alarms on (b)(6) 2016 as well as a hardware failure of (b)(6) 2016.These alarms point to an issue with maintenance and pre-analytic sample handling.Minimum sample volume must be considered and rack adapters are recommended for 13mm tubes.The affected reagent cassette was not available for investigation.Deteriorated reagent in the affected cassette cannot be excluded and issues with hardware and maintenance cannot be excluded.It may also be possible that the root cause is due to a defective cassette caused by freezing of the reagent.

• Brand Name: TINA-QUANT 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: 5510018
• MDR Text Key: 40645260
• Report Number: 1823260-2016-00325
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072714
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date: 05/24/2016

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 Catalogue Number: 04528123190
• Device Lot Number: 608019
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2016
• Initial Date FDA Received: 03/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/24/2016
• 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
• Patient Age: 63 YR