MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CHEMISTRY HBA1C DENATURANT REAGENT

Model Number ADVIA CHEMISTRY HBA1C DENATURANT REAGENT

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/28/2014

Event Type  malfunction  

Event Description

The customer has obtained discordant results on seventy three patient samples for the a1c3 assay on an advia chemistry 2400 instrument when using reagent lot 170.Quality control and slope adjustments for the assay were within specifications the day the samples were run.Results of seventy three patient samples were reported to physician(s).The samples were also run on an alternate platform and the results were lower.There were no reports of adverse health consequences due to the high a1c3 results on the patient samples.

Manufacturer Narrative

A siemens headquarters support center (hsc) representative has evaluated the patient data.The cause of the high results for a1c3 when using reagent lot 170 is unknown.Siemens diagnostics is investigating the issue.

Manufacturer Narrative

The initial mdr 2432235-2014-00703 was filed on december 4, 2014.Additional information (05/06/15): siemens technical operations investigated the issue which was reviewed on 5/6/15, where internal studies and testing on reagent lot 170 returned by the customer, showed no discordant patient results.Quality control samples and whole blood samples with assigned target values were tested with reagent lot 170 and recovered as per specifications.Additional information (5/8/2015): siemens headquarters support center (hsc) contacted the customer, and were informed on 5/8/15 that the customer had moved on to a different reagent lot and has had no problems.The cause of the falsely high results on patient samples for hemoglobin a1c_3 is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

• Brand Name: ADVIA CHEMISTRY HBA1C DENATURANT REAGENT
• Type of Device: ADVIA CHEMISTRY HBA1C DENATURANT REAGENT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS (REG# 2517506); 500 gbc drive; p.o. box 6101; newark DE 19714 6101
• Manufacturer Contact: aarti aziz ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242683
• MDR Report Key: 4296333
• MDR Text Key: 5058582
• Report Number: 2432235-2014-00703
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K081895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ADVIA CHEMISTRY HBA1C DENATURANT REAGENT
• Device Catalogue Number: 10286032
• Device Lot Number: 170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1