MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-23 for VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK 6801042 manufactured by Ortho-clinical Diagnostics.
[126380008]
The investigation confirmed lower than expected vitros myoglobin quality control results were obtained using a non-vitros quality control fluid in combination with two different reagent lots on two different vitros 5600 integrated systems. A definitive assignable cause of the event could not be determined. Multiple precision tests performed indicated that the vitros 5600 systems were performing as intended. The lower than expected vitros myog quality control results were reproducible across two vitros 5600 systems, therefore, an instrument related issue did not likely contribute to the event. An unknown issue related to the cliniqa controls in use, or the vitros myog reagent or calibrators could not be ruled out as contributing to the event. Additionally, improper fluid handling of the calibrators or cliniqa control fluids could not be ruled out as contributing to the event. A definitive assignable cause of the event could not be determined.
Patient Sequence No: 1, Text Type: N, H10
[126380009]
A customer obtained lower than expected vitros myoglobin quality control results using a non-vitros quality control fluid in combination with two different reagent lots on two different vitros 5600 integrated systems. Vitros myoglobin reagent lot 1365: cliniqa lot 1804042 l1 results of 54. 5, 54. 5, 53. 9, 54. 3, 53. 1, 54. 5, 52. 9, 53. 9, 53. 3, 53. 2, 53. 0, 53. 8, 53. 8, 54. 8, 55. 0, 53. 5, 55. 0, 53. 5, 53. 4, 53. 5, 53. 7, 54. 1, 54. 2, 53. 4, 52. 6, 52. 5, 53. 7, 51. 4, 52. 2, 52. 6, 51. 9, 51. 5, 52. 5, 52. 7, 54. 3, 54. 6, 53. 6, 50. 8, 51. 1, 51. 6, 51. 0, 51. 0, 51. 4, 51. 8, 51. 0, 51. 1, 52. 0, 52. 1, 52. 8, 52. 6, 52. 4, 51. 5, 52. 6, 50. 3, 51. 0, 52. 2, 51. 4, 50. 1, 52. 1, 52. 1, 50. 6, 50. 7, 50. 9, 50. 7, 51. 2, 51. 0, 51. 4, 49. 9, 50. 6, 51. 1, 51. 2, 50. 3, and 50. 5 ng/ml vs. The expected result of 65. 1 ng/ml. Vitros myoglobin reagent lot 1375: cliniqa lot 1804042 l1 results of 53. 6, 54. 3, 53. 4, 51. 6, 51. 6, 51. 1, 51. 4, 50. 6, 51. 8, 50. 0, 50. 7, 50. 3, 50. 6, 49. 9, 50. 5, 50. 4, 50. 6, 51. 6, 52. 7, 52. 1, 53. 0, 51. 6, 51. 6, 52. 5, 52. 6, 53. 4, 53. 7, 53. 1, 53. 5, 52. 8, 53. 1, 53. 3, 54. 2, and 53. 0 ng/ml vs. The expected result of 65. 1 ng/ml. Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected. The lower than expected vitros myoglobin results were generated from a non-patient fluid, however the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected. Ortho has not been made aware of allegation of actual patient harm as a result of the event. This report is number three of four mdr? S for this event. Four 3500a forms are being submitted for this event as four devices were involved. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007111389-2018-00162 |
| MDR Report Key | 7994340 |
| Date Received | 2018-10-23 |
| Date of Report | 2018-12-17 |
| Date of Event | 2018-09-24 |
| Date Mfgr Received | 2018-09-24 |
| Device Manufacturer Date | 2018-07-09 |
| Date Added to Maude | 2018-10-23 |
| 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 | 2018-10-23 |
| Catalog Number | 6801042 |
| Lot Number | 1375 |
| Device Expiration Date | 2019-06-13 |
| 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 | 2018-10-23 |