MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-08 for VITROS IMMUNODIAGNOSTIC PRODUCTS MYOG REAGENT PACK 6801042 manufactured by Ortho-clinical Diagnostics.
[52735598]
The investigation concluded that multiple lower than expected myog quality control results were obtained using a single non-vitros quality control level in combination with a vitros 5600 integrated system. The investigation could not determine a definitive assignable cause. A within run vitros tt4 marker precision test, used to assess instrument function, was not performed, therefore the vitros 5600 system could not be entirely ruled out as a contributing factor. Based on historical quality control results, a vitros myog reagent performance issue is not a likely contributor to the event, however the possibility that an unexpected vitros myog reagent performance issue or a pre-analytical sample handling issue contributing to the results could not be entirely ruled out. A definitive assignable cause for the event could not be determined.
Patient Sequence No: 1, Text Type: N, H10
[52735599]
The customer observed multiple lower than expected vitros myog results obtained from a single non-vitros biorad quality control fluid processed on a vitros 5600 integrated system. Biorad l5 control results of 110. 773, 107. 156, 116. 864, 114. 667, 113. 300, 115. 402, 115. 048, 109. 252, 111. 79, and 115. 014 ng/ml versus customer established baseline mean 127. 95 ng/ml. A biased result of the direction and magnitude observed may lead to inappropriate physician action if it were to occur undetected with patient samples. Ortho has not been made aware of any erroneous vitros myog patient results obtained or reported from the laboratory over the time frame of the event, however, the investigation cannot conclude that patient sample results were not affected or would not be affected if the event were to recur undetected. There was no reported allegation of patient harm as a result of this event. This report is number one of two 3500a forms filed for this event, as two devices were affected. This report corresponds to ortho clinical diagnostics (ortho). Complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007111389-2016-00140 |
| MDR Report Key | 5854541 |
| Date Received | 2016-08-08 |
| Date of Report | 2016-08-08 |
| Date of Event | 2016-07-15 |
| Date Mfgr Received | 2016-07-17 |
| Device Manufacturer Date | 2015-09-29 |
| Date Added to Maude | 2016-08-08 |
| 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 MYOG REAGENT PACK |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | DDR |
| Date Received | 2016-08-08 |
| Catalog Number | 6801042 |
| Lot Number | 1100 |
| Device Expiration Date | 2016-08-26 |
| 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 | 2016-08-08 |