MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-03-14 for ACCUPROBE GROUP B STREP TEST 2820B manufactured by Gen-probe Incorporated.
[4243482]
The technician at (b)(6) reported testing with the kit, bulk, group b strep, accuprobe (mn: (b)(4) bn: (b)(4)) and incorrectly used the reagents. Three samples which were originally negative were positive using the correct reagents. Although there was correction of the reported results, there existed the potential for false negative test results and the potential for delay in treatment of true positive test results. This not a device error or a failure with the product, but rather an operator error based on improper use of the reagent.
Patient Sequence No: 1, Text Type: D, B5
[11697889]
Evaluation not required. User error.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2024800-2014-00002 |
| MDR Report Key | 3680237 |
| Report Source | 06 |
| Date Received | 2014-03-14 |
| Date of Report | 2014-03-14 |
| Date of Event | 2014-01-07 |
| Date Mfgr Received | 2014-02-14 |
| Device Manufacturer Date | 2013-06-21 |
| Date Added to Maude | 2014-05-20 |
| 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 JOSEPH MCMULLEN |
| Manufacturer Street | 10210 GENETIC CENTER DRIVE |
| Manufacturer City | SAN DIEGO CA 921214362 |
| Manufacturer Country | US |
| Manufacturer Postal | 921214362 |
| Manufacturer Phone | 8584108897 |
| Manufacturer G1 | GEN-PROBE INCORPORATED |
| Manufacturer Street | 10210 GENETIC CENTER DRIVE |
| Manufacturer City | SAN DIEGO CA 92121436 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 4362 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCUPROBE GROUP B STREP TEST |
| Generic Name | GROUP B STREP |
| Product Code | MDK |
| Date Received | 2014-03-14 |
| Catalog Number | 2820B |
| Lot Number | 633429 |
| Device Expiration Date | 2014-01-15 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GEN-PROBE INCORPORATED |
| Manufacturer Address | 10210 GENETIC CENTER DRIVE SAN DIEGO CA 92121436 US 92121 4362 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-14 |