MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-16 for PLATELET PGD TEST P100T manufactured by Verax Biomedical Incoporated.
[127544543]
Verax requested: samples from the platelet units. The user facility has not provided samples. Slants containing the microorganisms identified from the platelet units. The hospital provided slants. Photographs or the ability to view the pgd test devices that were used to test the platelet unit, the residual samples, etc. The user facility has not provided any photos or allowed viewing of any the completed test devices. Verax requested: photographs of results of culture plates verax has not had access to this information. Additional access to laboratory personnel so that human-to-human troubleshooting could be performed. Verax has not been able to schedule such activities. Verax performed an investigation using representative platelet pgd test devices, the acinetobacter baumannii strain(s) provided by the hospital and in-date platelets purchased for in vitro diagnostic use. A. Baumannii was grown on blood agar plates. Live bacteria were then spiked into platelets and tested with the platelet pgd test. The pgd test was able to detect the organism identified at the user facility. As the user facility was not able to detect the organism using the pgd test, verax concludes that the concentrations of bacteria present in the platelet units tested at the hospital were below the level at which verax detected the organism. Verax does not know the concentration of bacteria in the samples tested at the user facility. Note: the user facility report included a "serial number" entry. The platelet pgd test does not have serial numbers. The verax platelet pgd test instructions for use section m, limitations, 9, states that "a non-reactive test result does not mean the unit is sterile or bacteria free. Non-reactive results may occur if... " section m. 9. C.. Provides one example as follows: "the concentration of bacteria is below the limit of detection of the test".
Patient Sequence No: 1, Text Type: N, H10
[127544544]
On october 1, the blood center manufactured two (2) apheresis platelet units in platelet additive solution/plasma from a single collection. Prior to distribution, platelets are subjected to primary testing for bacteria using a growth based quality control test and units are distributed as 'negative to date. ' the hospital received both units the evening of october 3. On the morning of october 4, hospital used the platelet pgd test as a secondary test to detect bacteria. The pgd results were non-reactive. The units reportedly looked "normal. " the units was transfused to hematopoietic stem cell transplant recipients. The recipients experienced serious septic transfusion reactions affecting their kidneys. The units were returned to the lab where samples were withdrawn and gram stained. Blood cultures were also performed. Gram stains were positive. Blood cultures were positive in about 2-3 hours. Acinetobacter baumannii, a gram-negative organism, was identified. Blood samples from the recipients were tested and determined to contain the same bacteria as in the platelet units. Discarded platelet samples were retrieved and tested with the platelet pgd test. The pgd results were non-reactive. During a phone conversation on oct. 10, a facility representative reported that the patients had improved. No further information has been received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005935106-2018-00001 |
| MDR Report Key | 8080180 |
| Date Received | 2018-11-16 |
| Date of Report | 2018-11-16 |
| Date of Event | 2018-10-04 |
| Date Mfgr Received | 2018-10-05 |
| Device Manufacturer Date | 2018-02-28 |
| Date Added to Maude | 2018-11-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. NANCY HORNBAKER |
| Manufacturer Street | 148 BARTLETT ST |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5087557029 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PLATELET PGD TEST |
| Generic Name | BACTERIAL DETECTION SYSTEM FOR PLATELETS FOR TRANSFUSION |
| Product Code | MZC |
| Date Received | 2018-11-16 |
| Catalog Number | P100T |
| Lot Number | 17355-001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VERAX BIOMEDICAL INCOPORATED |
| Manufacturer Address | 148 BARTLETT ST MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2018-11-16 |