MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2015-06-08 for BACT/ALERT BPN CULTURE BOTTLE 279019 manufactured by Boim?rieux, Inc..
[5902971]
(b)(6) informed biom? Rieux of a false negative result in association with the bact/alert bpn culture bottle (ref. 279018, lot 1040890, exp. 09aug15). A platelet pool sample was inoculated to the bact/alert bpn culture bottle on (b)(6) 2015. On (b)(6) 2015 (three days into the 7-day bact/alert bpn culture bottle test), the platelet pool associated with the bact/alert bpn culture bottle was transfused to a patient. The patient experienced a transfusional reaction as a consequence of the transfusion; the transfusion was stopped. The patient received treatment for the reaction and experienced no further incident. Though the hospital staff states a bacillus species was identified in the transfusion bag and in a blood specimen collected from the patient, the bact/alert bpn culture bottle was negative at 7 days. An investigation will be initiated by biom? Rieux. However, a platelet pool sample is unavailable for testing.
Patient Sequence No: 1, Text Type: D, B5
[13316144]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[33368899]
Due to prohibitive shelf-life, the customer did not submit platelet pool isolates for investigational testing. A bact/alert data back-up file was obtained from the customer. The bottle histories and readings for the bact/alert bpn bottle were extracted from the data backup. The histories were normal and showed the bottle flagged negative after 7 days. The readings were interpolated with an algorithm tool, and were determined negative. Statistical evaluation of the bottle readings indicates that both the fast and slow slope measurements show an initial spike but then diminished over time, and did not accumulate enough momentum for a signal. The investigation examined the bact/alert bpn lot 1040890 media formulation, filling, and packaging records, including the quality control acceptable quality limit inspection documentation and all the results were within specification. Retained samples from bact/alert bpn lot 1040890 were challenged in an internal study to confirm recovery of b. Cereus atcc 11778. The bact/alert bpn lot 1040890 performed as expected according to specification. The bact/alert bpn instructions for use (ifu) were reviewed. The platelet specimen collection and preparation section 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 ifu, the user is cautioned to take great care in order to prevent contamination, highlighting the importance of proper aseptic technique. The laboratory procedure states "negative cultures may be checked by smear and/or sub-culture at some point prior to discarding as negative. " additionally, it is stated "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. " the probable root cause was determined to be incorrect customer determination of the bottle results as "false" negative rather than "true" negative results. In order to determine that a bottle is truly positive, a sub-culture must be performed to confirm the presence of an organism. This confirmation step was not performed by the customer. The intended use of the bact/alert bpn bottles is for quality control and not for the release of the platelet product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2015-00041 |
| MDR Report Key | 4824031 |
| Report Source | 01,05,06 |
| Date Received | 2015-06-08 |
| Date of Report | 2015-06-03 |
| Date of Event | 2015-05-11 |
| Date Mfgr Received | 2015-06-03 |
| Device Manufacturer Date | 2014-08-14 |
| Date Added to Maude | 2015-06-08 |
| 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 | 0 |
| Event Location | 0 |
| 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 | BIOM |
| 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 BPN CULTURE BOTTLE |
| Generic Name | BACT/ALERT BPN |
| Product Code | LRG |
| Date Received | 2015-06-08 |
| Catalog Number | 279019 |
| Lot Number | 1040890 |
| Device Expiration Date | 2015-08-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOIM?RIEUX, INC. |
| Manufacturer Address | 100 RODOLPHE STREET DURHAM 27712 US 27712 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-06-08 |