MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-16 for VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK 6801042 manufactured by Ortho-clinical Diagnostics.
[85782166]
The investigation confirmed that lower than expected myoglobin results were obtained from a non-vitros quality control fluid using vitros immunodiagnostics products myoglobin reagent pack lot 1220 on a vitros 5600 integrated system (b)(4). The assignable cause is attributed to user error associated with an unknown maintenance issue as the qc shift low occurred after the customer performed maintenance actions on the vitros 5600 integrated system. The same biorad qc fluid was run on the customers alternative analyzer without experiencing the same shift. A review of the historical qc results for vitros myoglobin indicates performance was acceptable prior to and up to the date of the maintenance, and therefore vitros myoglobin lot 1220 performance issue is not a likely contributor to the event. The customer repeated the maintenance actions of cleaning the microwell incubator, the signal reagent probe, the well wash probe, and replacing the vapor adsorption cartridge and subsequent qc results were acceptable.
Patient Sequence No: 1, Text Type: N, H10
[85782167]
The customer observed lower than expected myoglobin results obtained from a non-vitros quality control (qc) fluid using vitros immunodiagnostic products myoglobin reagent pack on a vitros 5600 integrated system. Biorad level 1 lot 23636 results: 84. 36, 82. 65, 85. 52, 88. 75, and 84. 44 ng/ml versus customer baseline mean 131 ng/ml. Biased results of the direction and magnitude observed may lead to inappropriate physician action if patient samples were affected and the event were to recur undetected. There was no allegation of patient harm as a result of this event. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007111389-2017-00125 |
| MDR Report Key | 6797104 |
| Date Received | 2017-08-16 |
| Date of Report | 2017-08-16 |
| Date of Event | 2017-07-25 |
| Date Mfgr Received | 2017-07-25 |
| Device Manufacturer Date | 2017-02-01 |
| Date Added to Maude | 2017-08-16 |
| 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 | 0 |
| Brand Name | VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | DDR |
| Date Received | 2017-08-16 |
| Catalog Number | 6801042 |
| Lot Number | 1220 |
| ID Number | 10758750001019 |
| Device Expiration Date | 2018-01-12 |
| 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 | 2017-08-16 |