MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-09-29 for NEWBORN SCREENING BLOOD-SPOT COLLECTION DEVICE manufactured by Ge Healthcare.
[1376173]
Since (b)(6) 2010, the laboratories administration of the (b)(6) state dept of health and mental hygiene has identified approximately 170 newborn screening test results for biotinidase deficiency with no biotinidase activity. There is a possibility that these results are associated with lot w092 of newborn screening blood-spot filter paper forms -specimen collection devices- mfg by ge healthcare. Dates of use: (b)(6) 2010 -- (b)(6) 2010. Diagnosis or reason for use: screening newborns for hereditary disorders.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5017623 |
| MDR Report Key | 1852869 |
| Date Received | 2010-09-29 |
| Date of Report | 2010-09-29 |
| Date of Event | 2010-09-22 |
| Date Added to Maude | 2010-10-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | NEWBORN SCREENING BLOOD-SPOT COLLECTION DEVICE |
| Product Code | NAK |
| Date Received | 2010-09-29 |
| Lot Number | W092 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE |
| Manufacturer Address | 14 WALKUP DR WESTBOROUGH MA 01581101 US 01581 1019 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2010-09-29 |