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

Catalog Number 04528123190

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2015

Event Type  malfunction  

Manufacturer Narrative

It was unknown if the initial reporter sent report to the fda.

Event Description

The customer experienced an issue with qc and patient results for hemoglobin a1c on integra 800 analyzer serial number (b)(4) over several days.The customer stated the patient results "are swinging wildly as much as 6, as in going from a 7 to a 13%".Around 500 patient samples were involved.Of the data provided for 75 patient samples, only the results for 15 were discrepant.The following data is initial result, followed by repeat result on 08/11/2015.Patient 1: 8.6%, 5.3%.Patient 2: 6%, 4.0%.Patient 3: 6.1%, 7.7%.Patient 4: 6.2%, 7.9%.Patient 5: 6.8%, 8.5%.Patient 6: 6.1%, 7.8%.Patient 7: 6.2%, 8.1%.Patient 8: 7%, 9.0%.Patient 9: 7.3%, 9.4%.Patient 10: 7.5%, 9.7%.Patient 11: 7.4%, 9.6%.Patient 12: 7.9%, 10.2%.Patient 13: 8.1%, 10.6%.Patient 14: 8.4%, 10.9%.Patient 15: 9.4%, 13.2%.All of the initial results were reported outside the laboratory.The repeat results were believed to be correct.Some patients were notified that they would be followed as diabetic based on the original values.Corrective reports and notifications were being sent.The patients were not adversely affected.The customer believed the issue was reagent pack related.The field service representative noted that when the shipment with the suspect reagent was received on 07/14/2015, it was very hot and humid locally.The field service representative checked the analyzer and could not determine a cause.He replaced the air dryers, checked the rotor light barrier adjustment, and ran a work station accuracy check which passed.He checked the calibration history and the customer ran calibration and qc which passed.

Manufacturer Narrative

Based on a statement from customer, only 2-3 reagent cassettes were affected.A specific root cause could not be identified as the affected reagent cassettes are not available for further investigation.It was assumed the reagent was damaged by the high temperature during shipment.

• 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
• 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: 5036518
• MDR Text Key: 25696202
• Report Number: 1823260-2015-04035
• 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: Health Professional
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Catalogue Number: 04528123190
• Device Lot Number: 60172801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 08/10/2015
• 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: 080 YR
• Patient Weight: 97