MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM; TRANSFERRIN, ANTIGEN, ANTISERUM, CONTROL

Catalog Number 20763454122

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2015

Event Type  malfunction  

Event Description

The customer reported that they received questionable results for a total of ten patient samples tested for tina-quant soluble transferrin receptor (stfr).Of the ten samples, nine were found to have erroneous results that were reported outside of the laboratory.The customer initially received a data alarm with one patient sample result.The reaction curve for the result was noted to be "jumpy" and not normal.All other results from that same day were then checked and 9 additional samples were noted to have "jumpy" reaction curves.These 9 sample results were not accompanied by alarms.The samples were repeated and results were different.The first results were reported outside of the laboratory.After noticing the issue, the laboratory communicated that there were faulty results and the repeat results were then reported outside of the laboratory.The reaction curves of other analytes appeared to be ok and these were not retested.Control results were stated to be ok on the morning of (b)(6) 2015.After the first patient results were generated, one control level was analyzed and found to be out of range.All controls were then analyzed approximately 3 hours later and all were within range.The patients were not adversely affected.The stfr reagent lot number was 606449.The reagent expiration date was asked for, but not provided.It was determined that the last calibration of the assay was performed on 05/13/2015.According to product labeling, calibration must be performed every 6 days.

Manufacturer Narrative

This event occurred in (b)(6).

Manufacturer Narrative

Investigations have determined that there is an imprecision with reagent lot 606449.Retention testing of the lot has shown that precision is outside of specifications.The root cause of the reagent lot imprecision is not known.The reagent lot was changed at the customer site and no further issues were reported.

• Brand Name: TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM
• Type of Device: TRANSFERRIN, ANTIGEN, ANTISERUM, CONTROL
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; na; ibaraki 312- 8504; JA 312-8504
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 4825172
• MDR Text Key: 5901002
• Report Number: 1823260-2015-03592
• Device Sequence Number: 1
• Product Code: DDG
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K003064
• 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: 06/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 20763454122
• Device Lot Number: 606449
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 05/25/2015
• 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
• Patient Sequence Number: 1
• Patient Age: 047 YR