MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-23 for COBAS P (701) POST ANALYTICAL SYSTEM P 701 05349966001 manufactured by Roche Diagnostics.
[109501446]
Unique identifier (udi)#: (b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[109501447]
The customer alleged an issue with patient sample identification on the cobas p 701 post analytical unit. The customer stated they could not retrieve the sample because the cobas p701 misread the sample barcode and truncated the last 4 digits of the sample id. When the tube was processed, the barcode (b)(6) was not completely decoded. Only the first 8 characters were decoded and the sample was stored with the sample id 10024441. The p701 was configured to accept 7 to 14 digits. There was no error message and the sample was accepted for storage since the barcode was within the configured length. There was no allegation of an adverse event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-01588 |
| MDR Report Key | 7536588 |
| Date Received | 2018-05-23 |
| Date of Report | 2018-06-12 |
| Date of Event | 2018-04-26 |
| Date Mfgr Received | 2018-05-02 |
| Date Added to Maude | 2018-05-23 |
| 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 | 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 | 0 |
| Brand Name | COBAS P (701) POST ANALYTICAL SYSTEM |
| Generic Name | AUTOMATED POST ANALYTICAL SYSTEM |
| Product Code | LXG |
| Date Received | 2018-05-23 |
| Model Number | P 701 |
| Catalog Number | 05349966001 |
| 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 | 2018-05-23 |