MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-01-26 for ACCUPROBE GROUP B STREPTOCOCCUS CULTURE ID KIT 2820B manufactured by Gen-probe Incorporated.
[21639686]
Gen-probe received a complaint related to a closed class i recall that occurred on (b)(6) 2008. The device is a group b strep test that is primarily used for the detection of group b streptococcus at (b)(6) of pregnancy. A maternal specimen was tested on or about (b)(6) 2008 with this device. The test was negative for group b strep. The mother delivered a baby boy on (b)(6) 2008 via vaginal delivery. On (b)(6) 2008, the baby was admitted to the hospital because of persistent low-grade fever and decreased left arm movement. The lawsuit states he was ultimately diagnosed with osteomyelitis, an acute bone infection, most commonly due to group b strep. The lawsuit states he continues to suffer from the effect of this infection. The kit lot number associated with this event has not been confirmed by the lab that performed the testing, although the reporter of the incident has indicated this may be the same lot number that was subject to a recall as described on this report.
Patient Sequence No: 1, Text Type: D, B5
[21857933]
The kit lot number associated with this event has not been confirmed by the lab that performed the testing, although the reporter of the incident has indicated this may be the same lot number (555368) that was subject to a recall as described below. (b)(4) kit lot number 555368 was subject to a recall on (b)(6) 2008 due to kits potentially containing empty, or partially empty tubes labeled as containing probe reagent. If an empty or partially empty tube is used for the positive control, this could result in a delay in correctly identifying the isolate due to an invalid run. Alternatively, if a filled probe tube is used for the positive control while an empty or partially empty probe tube is used for the patient testing, this could result in a false negative result. All reagents in the kit were labeled correctly. It is estimated that between 1% and 5% of the tubes used to test a sample for group b strep were defective for the impacted lots. This recall has been closed by fda. There are multiple potential reasons/causes for the infant contracting group b strep although the maternal specimen tested negative. Since the ivd test kit (the device) was used at the time of testing to perform the maternal test, it was not available for further evaluation or confirmation. The "method" and "results" evaluation codes indicated above reflect the recall investigation only. The "conclusions" code reflects the adverse event evaluation completed at this time. Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2024800-2012-00001 |
| MDR Report Key | 2429569 |
| Report Source | 07 |
| Date Received | 2012-01-26 |
| Date of Report | 2012-01-26 |
| Date of Event | 2008-12-30 |
| Date Mfgr Received | 2011-07-07 |
| Device Manufacturer Date | 2008-10-01 |
| Date Added to Maude | 2012-01-27 |
| 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 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DR. CHRISTINA YANG, PH.D, CQA, RAC |
| Manufacturer Street | 10210 GENETIC CENTER DRIVE |
| Manufacturer City | SAN DIEGO CA 921214362 |
| Manufacturer Country | US |
| Manufacturer Postal | 921214362 |
| Manufacturer Phone | 8584108703 |
| 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 STREPTOCOCCUS CULTURE ID KIT |
| Generic Name | MDK |
| Product Code | MDK |
| Date Received | 2012-01-26 |
| Catalog Number | 2820B |
| Lot Number | 555368 |
| Device Expiration Date | 2009-06-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Hospitalization | 2012-01-26 |