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 2019-12-18 for EASYMAG? INSTRUMENT - 200111 manufactured by Biomerieux Sa.
[188091728]
The device was not returned to the manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[188091729]
A customer from (b)(6) notified biomerieux of a contamination issue leading to false positive results and an overestimated result for polyoma bk virus result in association with the easymag? Instrument (ref. 200111, serial (b)(4)). The customer reported a patient? S urine sample containing high dose of polyoma bk virus has cross- contaminated four separate patient samples (serum samples) also being tested for polyoma bk. The customer confirmed the four patients were grafted male patients hospitalized at the time of the testing, and taking immunosuppressive therapy. The contamination resulted in false positive polyoma bk virus results for three patient samples. These three patients were retested two weeks later using the easymag? And all obtained negative results for polyoma bk virus. The customer confirmed one patient sample result was falsely overestimated for polyoma bk virus due to the contamination. This patient was confirmed positive by re-testing performed two weeks later. The customer stated for the three polyoma bk virus negative patients, the false positive results led to change of immunosuppressive drug dosage; therapy management for the fourth patient was not reported. Biomerieux will initiate an internal investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615037-2019-00043 |
| MDR Report Key | 9490273 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-12-18 |
| Date of Report | 2020-03-10 |
| Date Mfgr Received | 2020-02-11 |
| Date Added to Maude | 2019-12-18 |
| 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 | JENNIFER ARMSTRONG |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145068201 |
| Manufacturer G1 | BIOMERIEUX ITALIA S.P.A. |
| Manufacturer Street | VIA DI CAMPIGLIANO 58 / LOC. P 50012 BAGNO A RIPOLI |
| Manufacturer City | FIRENZE |
| Manufacturer Country | IT |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EASYMAG? INSTRUMENT - 200111 |
| Generic Name | EASYMAG? INSTRUMENT - 200111 |
| Product Code | JJH |
| Date Received | 2019-12-18 |
| 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 | 58 - LOC. PONTE A EMA 50012 BAGNO A RIPOLI FIRENZE IT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-12-18 |