MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-10-30 for COBAS INTEGRA 400 PLUS I400+ 04922859001 manufactured by Roche Diagnostics.
[91260497]
(b)(4). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[91260498]
The customer received questionable crplx c-reactive protein (latex) results for two patient samples. Patient 1 initial result was 0. 05 mg/l and the repeat result was 30. 45 mg/l. On (b)(6) 2017, patient 2 initial result was 0. 03 mg/l and the repeat results were 23. 59 and 23. 61 mg/l. This patient was a (b)(6) female. The erroneous results were not reported outside of the laboratory. There was no allegation of an adverse event. The reagent lot number was 21624101 with an expiration date of 31-oct-2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02446 |
| MDR Report Key | 6986526 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-10-30 |
| Date of Report | 2017-11-27 |
| Date of Event | 2017-10-07 |
| Date Mfgr Received | 2017-10-10 |
| Date Added to Maude | 2017-10-30 |
| 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 | 0 |
| 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 | ROCHE INSTRUMENT CENTER AG TEGIMENTA |
| Manufacturer Street | FORRENSTRASSE NA |
| Manufacturer City | ROTKREUZ 6343 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 6343 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS INTEGRA 400 PLUS |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | DCN |
| Date Received | 2017-10-30 |
| Model Number | I400+ |
| Catalog Number | 04922859001 |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-30 |