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 2018-07-26 for EASYMAG? INSTRUMENT 200111 manufactured by Biomerieux Sa.
[115685088]
A customer in france notified biom? Rieux of potential contamination associated with easymag? Instrument (reference (b)(4)). The customer reported that the laboratory suspects contamination with vzc (altona pcr) since (b)(6) 2018. The first two samples have a high signal of positivity with vzv. Six (6) samples were positive with vzv with a value greater than 31. The laboratory decided to retest these samples the next day. Four (4) of the samples tested positive. Results were reported as follows: results : swt1 = negative hsv and vzv; swt2 = ct value = 29. 9 for hsv1 and 42 for vzv; swt3 = negative hsv and vzv; swt4 = negative hsv and vzv contamination. Patients samples: (b)(6) positive with ct = 29 for hsv1. Id 2706619 positive with ct = 38 vzv. However, the negative control tests (pbs and w0) were negative. There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to a patient's state of health. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00114 |
| MDR Report Key | 7723642 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-07-26 |
| Date of Report | 2018-12-04 |
| Date Mfgr Received | 2018-11-08 |
| Date Added to Maude | 2018-07-26 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. TIFFANY HALL |
| Manufacturer Street | 100 RODOLPHE STREET |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal | 27712 |
| Manufacturer G1 | BIOMERIEUX SA |
| Manufacturer Street | VIA DI CAMPIGLIANO 58 - LOC. PONTE A EMA |
| Manufacturer City | 50012 BAGNO A RIPOLI, |
| Manufacturer Country | IT |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EASYMAG? INSTRUMENT |
| Generic Name | EASYMAG? INSTRUMENT |
| Product Code | JQW |
| Date Received | 2018-07-26 |
| Model Number | 200111 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX SA |
| Manufacturer Address | VIA DI CAMPIGLIANO 58 - LOC. PONTE A EMA 50012 BAGNO A RIPOLI, IT |
| Brand Name | EASYMAG? INSTRUMENT |
| Generic Name | EASYMAG? INSTRUMENT |
| Product Code | JJH |
| Date Received | 2018-07-26 |
| Model Number | 200111 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX SA |
| Manufacturer Address | VIA DI CAMPIGLIANO 58 - LOC. PONTE A EMA 50012 BAGNO A RIPOLI, IT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-26 |