MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-10-09 for ILLUMIGENE GROUP B STREPTOCOCCUS DNA AMPLIFCATION ASSAY 280350 manufactured by Meridian Bioscience, Inc..
[89149626]
Final quality control testing documentation review completed; product release specifications were satisfied. Certificate of analysis issued may 04, 2017. Evaluation of retain kit from same lot completed on 09/07/2017. Retain kit testing performed using qualified quality control positive specimens. Reported positive control results were as expected. Trending complaint review completed by technical support personnel. No other false positive complaints reported for lot number 20350j052. This is the first reported complaint for lot number 280350j052. Event maintained in meridian bioscience, inc. Customer complaint (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[89149627]
A (b)(6) old baby came to ((b)(6) hospital) ed with fever. Spinal tap and blood cultures were drawn. Csf and blood culture were positive for group b strep. Baby was transferred to (b)(6) neonatal icu and was on ventilator.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1524213-2017-00002 |
| MDR Report Key | 6933518 |
| Report Source | USER FACILITY |
| Date Received | 2017-10-09 |
| Date of Report | 2017-09-29 |
| Date of Event | 2017-08-30 |
| Date Mfgr Received | 2017-09-01 |
| Device Manufacturer Date | 2016-10-24 |
| Date Added to Maude | 2017-10-09 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SUSAN ROLIH |
| Manufacturer Street | 3471 RIVER HILLS DRIVE |
| Manufacturer City | CINCINNATI OH 45244 |
| Manufacturer Country | US |
| Manufacturer Postal | 45244 |
| Manufacturer Phone | 5132713700 |
| Manufacturer G1 | MERIDIAN BIOSCIENCE, INC. |
| Manufacturer Street | 3471 RIVER HILLS DRIVE |
| Manufacturer City | CINCINNATI OH 45244 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 45244 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ILLUMIGENE GROUP B STREPTOCOCCUS DNA AMPLIFCATION ASSAY |
| Generic Name | NUCLEIC ACID AMPLIFICATION ASSAY SYSTEM, GROUP B STREPTOCOCCUS |
| Product Code | NJR |
| Date Received | 2017-10-09 |
| Model Number | 280350 |
| Catalog Number | 280350 |
| Lot Number | 280350J052 |
| Device Expiration Date | 2018-04-14 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERIDIAN BIOSCIENCE, INC. |
| Manufacturer Address | 3471 RIVER HILLS DRIVE CINCINNATI OH 45244 US 45244 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2017-10-09 |