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 2016-12-13 for BACT/ALERT? BPN EU 279045 manufactured by Biomerieux Inc..
[62384801]
A customer from the (b)(6) reported to biom? Rieux a false negative for staphylococcus aureus in association with bact/alert? Bpn eu. A platelet unit was sampled for culture using the bact/alert? System and was determined to be negative after 7 days incubation. The subculture was also identified as negative. The platelet unit was split into two separate platelet packs. One pack was transfused without any negative impact to the patient. Two days later, the second pack was noticed to have "clots" so it was cultured with bact/alert? Bpn eu and was positive for staphylococcus aureus after 4 days of incubation. This second platelet pack was not transfused. There is no indication that the discrepant result led to any adverse event related to the patient's state of health. The bottle id's and backup data from the instrument's 3d control module have been requested from the customer. An internal biom? Rieux has been initiated.
Patient Sequence No: 1, Text Type: D, B5
[71007884]
An internal biom? Rieux investigation was conducted. The customer's initial testing with the bact/alert? Bpn bottle was performed before the platelets were split into two packs showing a negative result. The first pack was administered with no issues to the patient. The second pack after two days had a visible clot and when tested was positive for staphylococcus aureus. The second pack with the visible clot is indicative of contamination introduced when the platelets were split into two packs. The bact/alert? Bpn eu instructions for use were reviewed and it provides sufficient caution to the user on proper handling technique. Great care must be taken to prevent contamination of the platelet sample during inoculation into the culture bottles. Contamination could lead to a specimen being determined positive when a clinically relevant isolate is not actually present in the donated platelet unit. The investigation examined the bact/alert? Manufacturing directions, including the quality control release testing documentation, and all results were within specification. The investigation determined the most likely root cause is contamination during the division of the platelet sample. The bact/alert? Bpn eu bottles performed as expected during initial use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00509 |
| MDR Report Key | 6170472 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-12-13 |
| Date of Report | 2017-03-06 |
| Date Mfgr Received | 2017-02-09 |
| Date Added to Maude | 2016-12-13 |
| 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 | MRS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317301 |
| Manufacturer G1 | BIOMERIEUX INC. |
| Manufacturer Street | 100 RANDOLPHE STREET |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27712 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BACT/ALERT? BPN EU |
| Generic Name | BACT/ALERT? BPN EU |
| Product Code | MZC |
| Date Received | 2016-12-13 |
| Catalog Number | 279045 |
| Lot Number | 1046031 |
| Device Expiration Date | 2017-01-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX INC. |
| Manufacturer Address | 100 RANDOLPHE STREET DURHAM NC 27712 US 27712 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-13 |