MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-25 for VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS 1286293 manufactured by Ortho-clinical Diagnostics.
[101151215]
The investigation confirmed that higher than expected vitros ck-mb results were obtained for non-vitros qc fluids processed using vitros ck-mb reagent lot 2240 on a vitros 5600 integrated system (s/n (b)(4)). The assignable cause was determined to be a sub-optimal vitros ck-mb calibration as the qc performance was unacceptable immediately after a calibration event. The cause of the sub-optimal calibration could not be determined, although a pre-analytical handling or storage issue could not be completely ruled out. Based on historical quality control results, a vitros ck-mb reagent lot 2240 performance issue is not a likely contributor to this event. Following re-calibration of vitros ck-mb lot 2240 using the same reagent pack and a fresh set of calibrator fluids, acceptable qc performance was obtained.
Patient Sequence No: 1, Text Type: N, H10
[101151216]
The customer observed higher than expected vitros ck-mb quality control results obtained from non-vitros quality control (qc) fluids processed using vitros ck-mb reagent on a vitros 5600 integrated system. Cliniqa cardiac marker control level 1, lot 170616, results 4. 52, 4. 96 and 4. 99 ng/ml, versus expected result 3. 15 ng/ml biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected. No erroneous patient sample results were obtained or reported from the laboratory. Ortho was not made aware of any allegation of patient harm as a result of this event. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007111389-2018-00025 |
| MDR Report Key | 7295270 |
| Date Received | 2018-02-25 |
| Date of Report | 2018-02-25 |
| Date of Event | 2018-01-26 |
| Date Mfgr Received | 2018-01-28 |
| Device Manufacturer Date | 2017-10-13 |
| Date Added to Maude | 2018-02-25 |
| 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 | MEDICAL TECHNOLOGIST |
| 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 CK-MB CALIBRATORS |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | JIS |
| Date Received | 2018-02-25 |
| Catalog Number | 1286293 |
| Lot Number | 2240 |
| ID Number | 10758750008728 |
| Device Expiration Date | 2018-06-29 |
| 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 | 2018-02-25 |