MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-21 for VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK 1896836 manufactured by Ortho-clinical Diagnostics.
[44213505]
The investigation determined that non-reproducible, higher than expected vitros ckmb results were obtained from two different patient samples and a single non-vitros quality control fluid processed on the vitros 5600 system. The investigation could not determine a definitive assignable cause, however, it is likely the event was analyzer related, as no recurrence of non-reproducible, higher than expected vitros ckmb results have occurred since service actions were performed on the instrument. Since pre-service precision testing was not performed correctly, an analyzer related event cannot be confirmed. Additionally, since quality control fluid was affected, an unknown reagent related issue cannot be ruled out as contributing to the event. Finally, regarding the patient sample results, pre-analytical sample processing could not be ruled out as a contributing factor as the customer is not adhering to the sample collection device manufacturer? S recommendations for sample centrifugation. A definitive assignable cause for the event could not be determined.
Patient Sequence No: 1, Text Type: N, H10
[44213506]
The customer obtained non-reproducible, higher than expected vitros ckmb results from two different patient samples and a single non-vitros quality control fluid tested on a vitros 5600 system. Patient sample 1: result of 4. 58 ng/ml vs. The expected results of 0. 94 and 0. 68 ng/ml. Patient sample 2: result of 14. 9 ng/ml vs. The expected results of 1. 24 and 1. 29 ng/ml. Biorad control l1: result of 4. 60 ng/ml vs. The expected result of 2. 64 ng/ml. Biased results of the direction and magnitude observed may lead to inappropriate physician action. The non-reproducible, higher than expected vitros ckmb patient sample results were reported outside of the laboratory, however, corrected reports were sent to the physician. No treatment was given, changed, or withheld based on the non-reproducible, higher than expected ckmb patient results that were reported. There was no allegation of actual patient harm as a result of this event. This report is number two of two mdr's for this event. Two 3500a forms are being submitted for this event as two devices were involved. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007111389-2016-00063 |
| MDR Report Key | 5595405 |
| Date Received | 2016-04-21 |
| Date of Report | 2016-04-21 |
| Date of Event | 2016-03-17 |
| Date Mfgr Received | 2016-03-23 |
| Device Manufacturer Date | 2015-11-18 |
| Date Added to Maude | 2016-04-21 |
| 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 |
| 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 REAGENT PACK |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | JHX |
| Date Received | 2016-04-21 |
| Catalog Number | 1896836 |
| Lot Number | 1900 |
| Device Expiration Date | 2016-08-12 |
| 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 | 2016-04-21 |