MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-11-08 for TDX/TDXFLX CANNABINOIDS REAGENT 9671-60 manufactured by Abbott Health Products, Inc..
[15556934]
The customer stated that while pipetting x-systems cannabinoids controls from the positive control vial, she pushed so hard on the pipette (attempting to tighten a loose pipette tip to the pipette barrel) that the pipette tip went through the bottom of the control vial and punctured her finger causing it to bleed. The customer was not wearing gloves at the time of the event. The customer washed and rinsed the wound for 10 minutes. The abbott customer technical advocate (cta) discussed and referenced the precautions listed in the product's package insert. The customer consulted with a physician and went to the emergency department where she was administered a tetanus shot. There is no further impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[15991353]
Also reference 510(k)#: k874646 (delta-9 reformulation calibrators and controls). Why not code (h3): (a review of the complaint documentation identified that the event was caused by human error and did not involve the device nor was caused by a failure of the device). A review of the complaint documentation identified that the event occurred when the operator pushed too hard when pipetting a control sample, which punctured the bottom of the control bottle and in turn punctured the operator's finger. The event was not caused by a malufunction of the device or a product performance issue. The event was caused by user error. This event is addressed in the tdx/tdxflx cannabinoids package insert (34-3966/r7), warnings and precautions for users section and in the x-systems cannabinoids control package insert (34-39621/r10), precautions section, where documentation emphasizes that samples and reagents should be handled with appropriate biosafety practices. The investgation demonstrated that the tdxflx cannabinoids assay is performing within its intended use, label claims and specifications. No deficiency related to the performance of the device was identified. This is a final report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2623532-2006-00003 |
| MDR Report Key | 777850 |
| Report Source | 06 |
| Date Received | 2006-11-08 |
| Date of Report | 2006-10-31 |
| Date of Event | 2006-10-31 |
| Date Mfgr Received | 2006-10-31 |
| Date Added to Maude | 2006-11-08 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | DR DAVID BARCH, D-09Y6, AP6C-2 |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 600646092 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646092 |
| Manufacturer Phone | 8479379328 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TDX/TDXFLX CANNABINOIDS REAGENT |
| Generic Name | CANNABINOID TEST SYSTEM |
| Product Code | LDJ |
| Date Received | 2006-11-08 |
| Model Number | NA |
| Catalog Number | 9671-60 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 765623 |
| Manufacturer | ABBOTT HEALTH PRODUCTS, INC. |
| Manufacturer Address | KM 58.0, CARRETERA 2 CRUCE DAVILA BARCELONETA PR 00617 US |
| Baseline Brand Name | TDX/TDXFLX CANNABINOIDS REAGENT |
| Baseline Generic Name | CANNABINOID TEST SYSTEM |
| Baseline Model No | NA |
| Baseline Catalog No | 9671-60 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-11-08 |