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 2019-05-09 for ASSAY TIP/CUP ELECSYS MODULARE170 12102137001 manufactured by Roche Diagnostics.
[144555506]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[144555507]
The initial reporter complained of an issue with assay tip/cups from a particular batch number used with a cobas 6000 e 601 module with serial number (b)(4). There are cracks in the cups and the customer noticed a leak. When the customer switched to a different batch number there were no issues. A crack in the assay cup resulting in a leak could impact patient results. There was no allegation that questionable or erroneous results were generated at the customer site due to the leaking assay cup. There was no allegation that an adverse event occurred. The assay cups were requested for investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-01740 |
| MDR Report Key | 8594328 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-05-09 |
| Date of Report | 2019-08-23 |
| Date of Event | 2019-04-16 |
| Date Mfgr Received | 2019-04-16 |
| Date Added to Maude | 2019-05-09 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | ASSAY TIP/CUP ELECSYS MODULARE170 |
| Generic Name | EQUIPMENT, LABORATORY, GENERAL PURPOSE |
| Product Code | LXG |
| Date Received | 2019-05-09 |
| Model Number | NA |
| Catalog Number | 12102137001 |
| Lot Number | 19817113 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-05-09 |