MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-12-08 for AUTODELFIA NEONATAL 17A-OH-PROGESTERONE B015-112 manufactured by Wallac Oy.
[580553]
The event is associated with the use of the autodelfia neonatal 17a-oh-progesterone kit, which is intended for the quantitative determination of human 17a-oh-progesterone in blood specimens dried on filter paper as an aid in screening newborns for congenital adrenal hyperplasia (cah) using the 1235 autodelfia automatic immunoassay system. The lab called 11/8/06 about that they had found out that they had apparently missed a baby in the screening program. The baby became sick and was at the hosp in late october. The baby is reported to be recovering well. The original sample tested in 08/06 had been reported as negative, but when retested in 11/06, it was positive.
Patient Sequence No: 1, Text Type: D, B5
[7916457]
Initial investigations of the kit lot concerned has shown that the product is performing according to its specifications. Therefore, no recall need has been identified. The possible root cause for the negative result is currently being investigated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8043909-2006-00001 |
| MDR Report Key | 793835 |
| Report Source | 05,06 |
| Date Received | 2006-12-08 |
| Date of Report | 2006-12-08 |
| Date of Event | 2006-11-08 |
| Date Mfgr Received | 2006-11-08 |
| Device Manufacturer Date | 2006-07-01 |
| Date Added to Maude | 2006-12-14 |
| 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 | TOM STAHLBERG, SR. MGR |
| Manufacturer Street | P.O. BOX 10 |
| Manufacturer City | TURKU FIN-20101 |
| Manufacturer Country | FI |
| Manufacturer Postal | FIN-20101 |
| Manufacturer Phone | 22678111 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AUTODELFIA NEONATAL 17A-OH-PROGESTERONE |
| Generic Name | FLUOROIMMUNOASSAY/17-OH-PROGESTERONE |
| Product Code | JLX |
| Date Received | 2006-12-08 |
| Model Number | B015-112 |
| Catalog Number | B015-112 |
| Lot Number | 351 837 |
| ID Number | * |
| Device Expiration Date | 2007-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 781452 |
| Manufacturer | WALLAC OY |
| Manufacturer Address | PERKINELMER LAS TURKU FI FIN-20101 |
| Baseline Brand Name | AUTODELFIA NEONATAL 17A-OH-PROGESTERONE |
| Baseline Generic Name | FLUOROIMMUNOASSAY/17-OH-PROGESTERONE |
| Baseline Model No | B015-112 |
| Baseline Catalog No | B015-112 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2006-12-08 |