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 2016-02-24 for BACT/ALERT? BPA CULTURE BOTTLE 279044 manufactured by Biomerieux, Inc..
[38864678]
On (b)(6) 2016, a customer notified biomerieux that a (b)(6) patient had a transfusion reaction when going through a platelet transfusion (fever, tachycardia and vomiting) on (b)(6) 2015. The pooled platelet concentrate was originally tested using the bact/alert bpa reagent. The test result of the bact/alert reagent was a negative result after 7 days of incubation. After the patient experienced the transfusion reaction, the platelet bag as well as patient blood was tested. Testing from both sources were positive for enterococcus faecalis. The patient has since recovered after treatment with antibiotics.
Patient Sequence No: 1, Text Type: D, B5
[44908652]
An investigation into a false negative event while using the bact/alert? Bpa culture bottle was performed. The investigation examined the manufacturing and quality control records. No abnormalities or anomalies were found. Interview with the customer determined that no subculture or gram stain was performed on the bottles after they were determined negative. The most probable root cause was determined to be incorrect determination of the bottle results as false negative rather than true negative results, i. E. The bottle did not contain any organism. A review of the package insert was performed. Under the platelet specimen collection and preparation states "the leukocyte reduced platelet specimen must be collected using sterile procedures... To reduce the risk of contaminating the sampling site and sampling site coupler... The platelet specimen should be taken at least 24 hours after collection to allow for natural proliferation in the platelet product. " in the procedural notes and precautions section of the ifus, the user is cautioned to take great care in order to prevent contamination, highlighting the importance of proper aseptic technique. Likely causes of contamination are listed as: "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. " the laboratory procedure states "negative cultures may be checked by smear and/or subculture at some point prior to discarding as negative. " additionally, a note is included which states "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 were too small for detection, or a culture bottle/medium that does not support the growth of the organism. " based on the results of the investigation, the complaint could not be confirmed and the product is operating within specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00038 |
| MDR Report Key | 5456361 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-02-24 |
| Date of Report | 2016-02-10 |
| Date of Event | 2015-11-28 |
| Date Mfgr Received | 2016-02-10 |
| Date Added to Maude | 2016-02-24 |
| 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 | MR. RYAN LEMELLE |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318582 |
| 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 |
| Product Code | MZC |
| Date Received | 2016-02-24 |
| Catalog Number | 279044 |
| Lot Number | 3043326 |
| Device Expiration Date | 2016-02-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 1. Required No Informationntervention | 2016-02-24 |