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 2017-12-15 for ELECSYS PROCELL M 04880340190 manufactured by Roche Diagnostics.
[95770247]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[95770248]
The customer complained that quality control was not acceptable for multiple tests after the customer changed to a new lot of procell on all four of their cobas 8000 e 602 modules used on two lines. (b)(4). The customer stated that they had been using procell lot 28648701 before the problem occurred with the new lot of procell. The customer changed procell and cleancell and the problem continued. The customer tested multiple patient samples prior to the unacceptable quality control. Please see the attachment to this medwatch for relevant erroneous patient data. The erroneous results were reported outside of the laboratory and the customer informed the physicians regarding the erroneous results. There was no allegation of an adverse event. On (b)(6) 2017 the customer received quality control flags on both lines of the e 602 module with the new lot of procell. The customer changed the procell reagent with a different lot and quality control was acceptable. The different procell lot number was 28648701.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02953 |
| MDR Report Key | 7120797 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-12-15 |
| Date of Report | 2018-01-16 |
| Date of Event | 2017-11-17 |
| Date Mfgr Received | 2017-11-28 |
| Date Added to Maude | 2017-12-15 |
| 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 DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELECSYS PROCELL M |
| Generic Name | GENERAL PURPOSE REAGENT |
| Product Code | PPM |
| Date Received | 2017-12-15 |
| Model Number | NA |
| Catalog Number | 04880340190 |
| Lot Number | 276477 |
| 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 | 2017-12-15 |