MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2015-08-21 for VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK 1938570 manufactured by Ortho-clinical Diagnostics.
[23711009]
The investigation confirmed that a higher than expected vitros prog patient result was obtained using a vitros eci system when compared to the prog result obtained using an alternate prog methodology which was considered true. A definitive assignable cause could not be determined; however there was no prog qc processed on the day of the event and the vitros prog lot 2110 had expired one month prior. Laboratory protocol issues associated with not running qc prior to patient testing and using expired reagent are contributing factors to this event. There was no indication of an instrument issue; however, there was no precision testing performed to confirm this. A sample related issue, a reagent issue and/or an instrument issue cannot be ruled out as potential contributing factors to this event. Per ocd medical consult: if the patient does not experience any adverse reactions to the gonadotropins treatment, serious long term injury is not anticipated.
Patient Sequence No: 1, Text Type: N, H10
[23711010]
The customer complained that a higher than expected vitros prog patient result was obtained using a vitros eci system when compared to the prog result obtained using an alternate prog methodology which was considered true. Patient result: 1. 85 ng/ml vs expected 0. 56 ng/ml. Patient fertilization treatment was postponed based on the higher than expected vitros prog result. Therefore, this was classified as a potential health and safety event because medical action was taken (fertilization treatment discontinued). There was no allegation of patient harm made as a result of this event. This report corresponds to ortho clinical diagnostics inc. Complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007111389-2015-00272 |
| MDR Report Key | 5021218 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2015-08-21 |
| Date of Report | 2015-08-21 |
| Date of Event | 2015-07-20 |
| Date Mfgr Received | 2015-07-23 |
| Device Manufacturer Date | 2014-11-21 |
| Date Added to Maude | 2015-08-21 |
| 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 | 3 |
| Manufacturer Contact | MR. JAMES A STEVENS |
| Manufacturer Street | 100 INDIGO CREEK DRIVE |
| Manufacturer City | ROCHESTER NY 14626 |
| Manufacturer Country | US |
| Manufacturer Postal | 14626 |
| Manufacturer Phone | 5854533000 |
| Manufacturer G1 | ORTHO CLINICAL DIAGNOSTICS |
| Manufacturer Street | FELINDRE MEADOWS PENCOED |
| Manufacturer City | BRIDGEND, WALES CF355PZ |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CF35 5PZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | JLS |
| Date Received | 2015-08-21 |
| Catalog Number | 1938570 |
| Lot Number | 2110 |
| Device Expiration Date | 2015-06-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Address | 100 INDIGO CREEK DRIVE ROCHESTER NY 14626 US 14626 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-21 |