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 08/19/2015

Event Type  malfunction  

Manufacturer Narrative

Na.

Event Description

The customer reported that they received erroneous results for ten patient samples tested for tina-quant hemoglobin a1c gen.2 (hba1c) on an integra 400 plus analyzer.The customer stated that they had switched to a new cassette of the same reagent lot number when the erroneous results occurred.The customer stated that some of the initial results were accompanied by data flags, but could not provide information on which specific results were accompanied by data flags.All initial results were reported outside of the laboratory where they were questioned by a physician.After the sample results were questioned, the customer ran controls and these controls were out of range.Controls were repeated and these were within range, so then the samples were repeated.The repeat results were believed to be correct.The first sample initially resulted as 9.8 % and the repeat result was 6.2 %.The second sample initially resulted as 9.6 % and the repeat result was 6.5 %.The third sample initially resulted as 9.6 % and the repeat result was 6.2 %.The fourth sample initially resulted as 12.1 % and the repeat result was 8.6 %.The fifth sample initially resulted as 10.5 % and the repeat result was 8.6 %.The sixth sample initially resulted as 9.5 % and the repeat result was 6.0 %.The seventh sample initially resulted as 11.4 % and the repeat result was 7.9 %.The eighth sample initially resulted as 14.5 % and the repeat result was 9.8 %.The ninth sample initially resulted as 10.2 % and the repeat result was 7.2 %.The tenth sample initially resulted as 14.3 % and the repeat result was 9.9 %.The patients were not adversely affected.The integra 400 plus analyzer serial number was 39-9439.The field service representative stated that the customer determined that the reagent cassette was bad.The customer replaced the cassette and calibrated the new cassette.

Manufacturer Narrative

The affected cassette was provided for investigation, but could not be investigated since the reagent had leaked out of the cassette during shipment back to the manufacturer.The customer has not had any additional issues and cassettes from the same lot and same shipment are being used.A specific root cause could not be determined based on the provided information.

• 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: 5083609
• MDR Text Key: 26113027
• Report Number: 1823260-2015-04179
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951595
• 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: Followup
• Report Date: 10/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2015
• 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: 60172801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 08/25/2015
• 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