MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-04-06 for ACCUPROBE GROUP B STREPTOCOCCUS CULTURE ID KIT 2820B manufactured by Gen-probe Incorporated.
[1521685]
The device is a group b (b) (6) test that is primarily used for the detection of group b (b) (6) at 36-38 weeks of pregnancy. A maternal specimen was tested in (b) (6) 2008 with this device from a batch that was subsequently recalled. The test was negative for group b (b) (6). The mother delivered on (b) (6) 2009, the child presented at an emergency room on (b) (6) 2009, and the child died from massive group b strep infection on (b) (6) 2009.
Patient Sequence No: 1, Text Type: D, B5
[8595953]
The kit lot number (555368) of this device was subject to a recall 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 test 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 were defective in the impacted lots. There are multiple potential reasons/causes for the infant contracting group b (b) (6) in (b) (6) 2009, although, the maternal specimen tested negative in (b) (6) 2008. The ivd test kit (the device) was used up at the time of testing and is not available for further evaluation or confirmation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2024800-2010-00001 |
| MDR Report Key | 1652529 |
| Report Source | 06 |
| Date Received | 2010-04-06 |
| Date of Report | 2010-04-06 |
| Date of Event | 2009-01-24 |
| Date Mfgr Received | 2010-03-10 |
| Device Manufacturer Date | 2008-10-01 |
| Date Added to Maude | 2010-04-07 |
| 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 | CHRISTINA YANG, PH.D. |
| Manufacturer Street | 10210 GENETIC CENTER DRIVE |
| Manufacturer City | SAN DIEGO CA 921214362 |
| Manufacturer Country | US |
| Manufacturer Postal | 921214362 |
| Manufacturer Phone | 8584108703 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCUPROBE GROUP B STREPTOCOCCUS CULTURE ID KIT |
| Product Code | MDK |
| Date Received | 2010-04-06 |
| Catalog Number | 2820B |
| Lot Number | 555368 |
| Device Expiration Date | 2009-06-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Death | 2010-04-06 |