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 03/25/2015

Event Type  malfunction  

Event Description

The customer questioned results for patient samples tested for tina- quant hemoglobin a1cdx gen.2 hemolysate application - standardized according to ifcc transferable to dcct/ngsp (a1cx2).The total number of patients affected could not be provided.The customer estimated that approximately 50-100 patients were involved.Of the data provided for 21 patient samples, all 21 were found to be erroneous.The customer realized while running the tests that the patient results were not feasible and ran quality controls on the cassette (reagent lot 693374-01).The customer indicated the control results were too high on this cassette.The customer removed this cassette from the device and inserted a new cassette with the same lot number.The customer calibrated the instrument, ran quality controls and repeated the patient samples.The patient results from the 2nd cassette (reagent lot 693374- 01) were considered to be correct.The patient results from the 1st cassette had been reported outside of the laboratory.The physicians were contacted and informed of the incorrect results within 24 hours.The incorrect results had no impact on patient therapy and no adverse event occurred.Patient sample 1 initial a1cx2 result from the 1st cassette was 10.4%.The repeat result from the 2nd cassette was 6.4%.Patient sample 2 ((b)(6) year old female) initial a1cx2 result from the 1st cassette was 8.2%.The repeat result from the 2nd cassette was 5.8%.Patient sample 3 ((b)(6) year old male) initial a1cx2 result from the 1st cassette was 9.1%.The repeat result from the 2nd cassette was 6.2%.Patient sample 4 ((b)(6) year old male) initial a1cx2 result from the 1st cassette was 8.3%.The repeat result from the 2nd cassette was 5.4%.Patient sample 5 ((b)(6) year old male) initial a1cx2 result from the 1st cassette was 12.0%.The repeat result from the 2nd cassette was 8.6%.Patient sample 6 ((b)(6) year old female) initial a1cx2 result from the 1st cassette was 8.6%.The repeat result from the 2nd cassette was 6.2%.Patient sample 7 ((b)(6) year old male) initial a1cx2 result from the 1st cassette was 9.7%.The repeat result from the 2nd cassette was 6.7%.Patient sample 8 ((b)(6) year old female) initial a1cx2 result from the 1st cassette was 10.0%.The repeat result from the 2nd cassette was 7.0%.Patient sample 9 ((b)(6) year old female) initial a1cx2 result from the 1st cassette was 12.7%.The repeat result from the 2nd cassette was 8.7%.Patient sample 10 ((b)(6) year old male) initial a1cx2 result from the 1st cassette was 8.1%.The repeat result from the 2nd cassette was 5.2%.Patient sample 11 ((b)(6) year old male) initial a1cx2 result from the 1st cassette was 8.7%.The repeat result from the 2nd cassette was 5.7%.Patient sample 12 ((b)(6) year old male) initial a1cx2 result from the 1st cassette was 7.4%.The repeat result from the 2nd cassette was 5.1%.Patient sample 13 ((b)(6) year old male) initial a1cx2 result from the 1st cassette was 12.1%.The repeat result from the 2nd cassette was 8.4%.Patient sample 14 ((b)(6) year old female) initial a1cx2 result from the 1st cassette was 9.2%.The repeat result from the 2nd cassette was 5.8%.Patient sample 15 ((b)(6)year old female) initial a1cx2 result from the 1st cassette was 9.0%.The repeat result from the 2nd cassette was 5.7%.Patient sample 16 ((b)(6) year old male) initial a1cx2 result from the 1st cassette was 8.2%.The repeat result from the 2nd cassette was 5.3%.Patient sample 17 ((b)(6) year old male) initial a1cx2 result from the 1st cassette was 10.1%.The repeat result from the 2nd cassette was 5.7%.Patient sample 18 ((b)(6) year old female) initial a1cx2 result from the 1st cassette was 10.2%.The repeat result from the 2nd cassette was 5.8%.Patient sample 19 ((b)(6) year old female) initial a1cx2 result from the 1st cassette was 11.4%.The repeat result from the 2nd cassette was 5.6%.Patient sample 20 ((b)(6) year old male) initial a1cx2 result from the 1st cassette was 15.6%.The repeat result from the 2nd cassette was 10.3%.Patient sample 21 ((b)(6) year old female) initial a1cx2 result from the 1st cassette was 10.3%.The repeat result from the 2nd cassette was 5.8%.The cobas integra 800 analyzer serial number was (b)(4).The most recent service date for the analyzer was (b)(6) 2015.

Manufacturer Narrative

This event occurred in (b)(6).

Manufacturer Narrative

During the investigation, a retention cassette of the same lot that the customer used was calibrated and controls were run.Controls were also run on the customer's cassette without new calibration.Control recovery with the retention cassette was within specification.Control recovery with the customer's cassette was out of specification.The customer's cassette was calibrated and controls were run again.Control recovery was now within specification.The calibration with the customer's cassette showed lower signals in comparison to the retention cassette.A visual examination of the reagent showed a yellow coloring of r2 in the customer's cassette.The retention reagent was without color.A specific root cause could not be identified.The root cause of the discrepant results was most likely the discoloring of r2 on the customer's reagent, however, the cause of this is unknown.The damage to the customer's cassette might be due to incorrect storage at the customer site or the damage could have occurred during transport.There is no indication that this issue is due to a systemic problem with the roche product as other complaints of this nature have been received.

• 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) 6830 5; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 4679667
• MDR Text Key: 5625092
• Report Number: 1823260-2015-02886
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K072714
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/20/2015

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 Catalogue Number: 04528123190
• Device Lot Number: 693374-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: 03/26/2015
• Initial Date FDA Received: 04/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/20/2015
• 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
• Patient Sequence Number: 1
• Patient Age: 059 YR