MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-06-17 for TINA-QUANT ALBUMIN GEN 2 04469658190 manufactured by Roche Diagnostics.
[13969848]
A specific root cause could not be determined based on the provided information. Investigations conclude that the root cause is most likely due to a compromised reagent pack.
Patient Sequence No: 1, Text Type: N, H10
[22405842]
It was unknown if the initial reporter sent a report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[22405843]
The customer reported that they received questionable results for a total of ten patient urine samples tested for tina-quant albumin gen. 2 (microalbumin). Of the ten samples, six had erroneous results that were reported outside of the laboratory. The samples were initially tested on the c502 analyzer and the initial results were reported outside of the laboratory. The samples were then later pulled on (b)(6) 2015 for reagent lot comparison testing on a c702 analyzer. The customer noted that the initial results from the c502 looked questionable when compared to the results from the c702 analyzer. A new reagent pack was then loaded on the c502 analyzer and the samples were then repeated on the c502 analyzer on (b)(6) 2015. The repeated results from the c502 analyzer were believed to be correct and were reported to the physicians. The first sample initially resulted as 51 mg/l on the c502 analyzer. The sample was repeated on (b)(6) 2015 on the c702 analyzer with reagent lot 602215, resulting as 103. 5 mg/l. The sample was repeated again on (b)(6) 2015 on the c702 analyzer with reagent lot 607851, resulting as 97. 1 mg/l. The sample was repeated on the c502 analyzer on (b)(6) 2015, resulting as 110 mg/l. The second sample initially resulted as 21 mg/l on the c502 analyzer. The sample was repeated on (b)(6) 2015 on the c702 analyzer with reagent lot 602215, resulting as 17. 6 mg/l. The sample was repeated again on (b)(6) 2015 on the c702 analyzer with reagent lot 607851, resulting as 15. 6 mg/l. The sample was repeated on the c502 analyzer on (b)(6) 2015, resulting as 15 mg/l. The third sample initially resulted as 18 mg/l on the c502 analyzer. The sample was repeated on (b)(6) 2015 on the c702 analyzer with reagent lot 602215, resulting as 47. 0 mg/l. The sample was repeated again on (b)(6) 2015 on the c702 analyzer with reagent lot 607851, resulting as 41. 6 mg/l. The sample was repeated on the c502 analyzer on (b)(6) 2015, resulting as 40. 9 mg/l. The fourth sample initially resulted as 30 mg/l on the c502 analyzer. The sample was repeated on (b)(6) 2015 on the c702 analyzer with reagent lot 602215, resulting as 78. 6 mg/l. The sample was repeated again on (b)(6) 2015 on the c702 analyzer with reagent lot 607851, resulting as 73. 4 mg/l. The sample was repeated on the c502 analyzer on (b)(6) 2015, resulting as 75 mg/l. The fifth sample initially resulted as 105 mg/l on the c502 analyzer. The sample was repeated on (b)(6) 2015 on the c702 analyzer with reagent lot 602215, resulting as 64. 5 mg/l. The sample was repeated again on (b)(6) 2015 on the c702 analyzer with reagent lot 607851, resulting as 60. 6 mg/l. The sample was repeated on the c502 analyzer on (b)(6) 2015, resulting as 62. 7 mg/l. The sixth sample initially resulted as 4 mg/l on the c502 analyzer. The sample was repeated on (b)(6) 2015 on the c702 analyzer with reagent lot 602215, resulting as 23. 2 mg/l. The sample was repeated again on (b)(6) 2015 on the c702 analyzer with reagent lot 607851, resulting as 17. 2 mg/l. The sample was repeated on the c502 analyzer on (b)(6) 2015, resulting as 19. 2 mg/l. The patients were not adversely affected. The c502 analyzer in use at the time of the incident was serial number (b)(4). The customer believed the pack in use at the time the original results were obtained may have been compromised in some manner when they took it off the analyzer, stored it in the refrigerator for some unknown length of time, then placed the pack back on the analyzer for testing. The customer declined service.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2015-03665 |
| MDR Report Key | 4851303 |
| Report Source | 05,06 |
| Date Received | 2015-06-17 |
| Date of Report | 2015-07-13 |
| Date of Event | 2015-05-27 |
| Date Mfgr Received | 2015-05-28 |
| Date Added to Maude | 2015-06-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | HITACHI HIGH TECH CORP. |
| Manufacturer Street | 882 ICHIGE HITACHINAKA NA |
| Manufacturer City | IBARAKI 312-8504 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 312-8504 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TINA-QUANT ALBUMIN GEN 2 |
| Generic Name | ALBUMIN, ANTIGEN, ANTISERUM, CONTROL |
| Product Code | JIR |
| Date Received | 2015-06-17 |
| Model Number | NA |
| Catalog Number | 04469658190 |
| Lot Number | 69591501 |
| ID Number | NA |
| Device Expiration Date | 2015-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-17 |