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 2016-07-26 for BACT/ALERT? BPA CULTURE BOTTLE 279044 manufactured by Biomerieux, Inc.
[50673054]
A customer notified biomerieux that they had a discrepant result when using the bact/alert reagent. The test result of the bact/alert reagent was negative after 6 days of incubation. The customer did not subculture the bact/alert bottle prior to disposal. Prior to transfusion of the platelets, the healthcare professional identified that the platelet bag was turbid. Testing of the platelet bag was positive for serratia marcescens.
Patient Sequence No: 1, Text Type: D, B5
[57606909]
This report was initially submitted following notification that a customer in the (b)(6) reported a false negative result in association with the bact/alert? Bpa culture bottle. The investigation examined the bact/alert? Bpa eu lot 3045498 and bpn eu lot 3044709 manufacturing directions, including the quality control release testing documentation and all results were within specification. Quality assurance subsequently released the lots for distribution to the field on 29jan16 and 20nov15 respectively. The most probable root cause was determined to be contamination of the sample during the platelet sample collection process. It is unknown if the serratia marcescens organism isolated from the platelet bag was also present in the donor sample, and therefore the bottles, in sufficient quantities to trigger the algorithm as a positive bottle. The bact/alert? Bpa eu and bpn eu ifus were reviewed. The procedural notes and precautions states "great care must be taken to prevent contamination of the platelet sample during inoculation into the culture bottles. Likely causes of contamination can occur from inadequate aseptic/sterile technique or operator error (e. G. , operator lab coat, aerosol), sampling or inoculation in an inadequate environment, or a spore present on top of the bact/alert? Bottle septum when introducing the specimen which was not removed with the 70% alcohol wipe. " additionally, the first note in the laboratory procedure cautions the user: "note: a report of "negative" should not be interpreted as meaning that the original product is sterile. The negative status could be due to under-inoculation of the bottle, no organisms present in the inoculum, the number of organisms was too small for detection, or a culture bottle/medium that does not support the growth of the organism. " bact/alert? Bpa and bpn eu ifus provide sufficient caution to the user on the importance of proper aseptic technique and interpretation of a negative result. The investigation concluded there is no evidence to suggest the bact/alert? Bpa culture bottle is performing outside of specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00130 |
| MDR Report Key | 5822766 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-07-26 |
| Date of Report | 2016-06-29 |
| Date Mfgr Received | 2016-06-29 |
| Date Added to Maude | 2016-07-26 |
| 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 RODOLPHE 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? BPA CULTURE BOTTLE |
| Generic Name | BACT/ALERT? BPA CULTURE BOTTLE |
| Product Code | MZC |
| Date Received | 2016-07-26 |
| Catalog Number | 279044 |
| Lot Number | 3045498 |
| Device Expiration Date | 2016-11-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX, INC |
| Manufacturer Address | 100 RODOLPHE STREET DURHAM NC 27712 US 27712 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-26 |