MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-09-18 for COBAS 4000 C (311) STAND ALONE SYSTEM C311 04826876001 manufactured by Roche Diagnostics.
[87320006]
Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[87320007]
The customer stated they had received an erroneous urine albt2 tina-quant albumin gen. 2 (albt2) result on the cobas 4000 c (311) stand alone system analyzer. The customer received an initial albt2 result of 242. 6 umol/l with a data flag and the repeat result with an automatic dilution was 12 umol/l with a data flag. The same sample was repeated again on the same c311 analyzer with an initial albt2 result of 12 umol/l and the repeat result with a 1:50 automatic dilution was 236. 7 umol/l with a data flag. On (b)(6) 2017 the same sample repeated on the same c311 with a 1:5 manual dilution resulted as 129. 4 umol/l and was reported outside the laboratory. On (b)(6) 2017 the same sample was repeated on the same c311 analyzer with an initial albt2 result of 12 umol/l with a data flag and the repeat result with a 1:20 automatic dilution was 231. 7 umol/l with a data flag. On (b)(6) 2017 the same sample was repeated on the same c311 with a 1:5 automatic dilution resulted in an albt2 as 126. 3 umol/l. The same sample repeated on the same c311 with a 1:5 manual dilution gave an albt2 raw value of 24. 6 umol/l and calculated as 123 umol/l when accounting for the dilution factor. The same sample repeated on a cobas 6000 c (501) module at a sister facility resulted as 240 umol/l and was believed to be correct. The customer verified that no other patient samples were affected and the calibration and quality control were within specification. There was no adverse event. The reagent lot number was 241675. The expiration date was requested but not provided. The field service engineer was unable to find a cause. He performed an instrument performance check that was within specification. A precision with patient sample and quality control were within specification.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02009 |
| MDR Report Key | 6872392 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-09-18 |
| Date of Report | 2017-12-27 |
| Date of Event | 2017-08-22 |
| Date Mfgr Received | 2017-08-24 |
| Date Added to Maude | 2017-09-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| 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 | COBAS 4000 C (311) STAND ALONE SYSTEM |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CJW |
| Date Received | 2017-09-18 |
| Model Number | C311 |
| Catalog Number | 04826876001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Brand Name | COBAS 4000 C (311) STAND ALONE SYSTEM |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-09-18 |
| Model Number | C311 |
| Catalog Number | 04826876001 |
| Lot Number | NA |
| ID Number | NA |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-18 |