MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-08 for VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK 1896836 manufactured by Ortho-clinical Diagnostics.
[138221041]
The investigation determined that a lower than expected vitros ck-mb result from a non-vitros mas thermofisher quality control (qc) fluid was attained using vitros ck-mb reagent in combination with a vitros 5600 integrated system. A definitive assignable cause could not be determined. An issue relating to the performance of vitros ck-mb reagent lot 2430 could not be ruled out as a contributor to the event. The customer was not processing both levels of mas qc fluids on a daily basis leading up to the event; therefore, the daily performance of the reagent was not verified by the customer. The customer? S baseline mean was considerably lower than the package insert mean for the mas xl1 fluid and the customer? S historical qc results leading up to the event were also lower than their baseline mean. However, ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros ck-mb reagent lot 2430. Due to the reoccurrence of low mas qc fluid results obtained by the customer, ortho recommended the customer contact thermofisher to discuss the stability of the mas qc fluids. Ortho sent the customer cliniqa qc fluids and alternative vitros ck-mb lot 2430 reagent packs. The customer has since run three levels of cliniqa fluids, on a daily basis on alternative packs, and the results have shown acceptable accuracy and within laboratory precision. An ortho field engineer visited the customer site to verify the performance of the vitros 5600 integrated system. However, no pre or post-service precision testing was conducted on the vitros 5600 integrated system. Therefore, the performance of the instrument was not verified and cannot be ruled out as a contributor to the event. Furthermore, ortho was able to determine that the customer was not following the correct procedures for weekly maintenance relating to the microwell incubator. Incubator contamination could have contributed to the event, but this could not be confirmed.
Patient Sequence No: 1, Text Type: N, H10
[138221042]
A customer reported a lower than expected vitros ck-mb result obtained from a non-vitros mas thermofisher quality control (qc) fluid using vitros immunodiagnostics products ck-mb reagent in combination with a vitros 5600 integrated system. Mas xl1 vitros ck-mb result of 3. 218 ng/ml versus the customer? S estimated baseline mean of 4. 43 ng/ml biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples. The result stemmed from a qc fluid, however, the investigation could not confirm that patient samples would not be affected if the event were to recur undetected. There were no allegations of patient harm as a result of this event. This report corresponds to ortho clinical diagnostics inc. Complaint numbers (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007111389-2019-00027 |
| MDR Report Key | 8322599 |
| Date Received | 2019-02-08 |
| Date of Report | 2019-02-08 |
| Date of Event | 2019-01-14 |
| Date Mfgr Received | 2019-01-14 |
| Device Manufacturer Date | 2018-09-10 |
| Date Added to Maude | 2019-02-08 |
| 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 CK-MB REAGENT PACK |
| Generic Name | IN VITRO DIAGNOSTICS |
| Product Code | JHX |
| Date Received | 2019-02-08 |
| Catalog Number | 1896836 |
| Lot Number | 2430 |
| Device Expiration Date | 2019-06-21 |
| 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 | 2019-02-08 |