MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-28 for VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK 6802892 manufactured by Ortho-clinical Diagnostics.
[146637211]
The investigation determined that higher than expected vitros ipth results were obtained from two different samples collected from the same patient, tested on a vitros 5600 integrated system, when compared to results obtained from a non-vitros (roche) system. The investigation determined the assignable cause of the event was the presence of heterophilic antibodies in the patient? S sample that are interfering with the vitros ipth assay. The? Other limitations? Section of the vitros ipth ifu, contains the following statement:? Heterophilic antibodies in serum or plasma samples may cause interference in immunoassays. These antibodies may be present in blood samples from individuals regularly exposed to animals or who have been treated with animal serum products. Results which are inconsistent with clinical observations indicate the need for additional testing?. Based on the historical ipth quality control performance, a vitros ipth reagent issue is not a likely contributing factor to this event. Ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros ipth reagent lot 0930 or vitros ipth reagent lot 1010. In addition, there was no indication of a vitros 5600 system issue and an instrument malfunction is not a likely contributor to the event.
Patient Sequence No: 1, Text Type: N, H10
[146637212]
A customer obtained higher than expected vitros ipth results from two different samples collected from the same patient, tested on a vitros 5600 integrated system, when compared to results obtained from a non-vitros (roche) system. 2018 patient sample vitros ipth result of 160. 5 pg/ml versus the expected roche result of 61 pg/ml. 2019 patient sample vitros ipth result of 126. 1 pg/ml versus the expected roche result of 57 pg/ml. Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected. The higher than expected vitros ipth results were reported outside the laboratory. However, the results were questioned by a clinician. 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. This report corresponds to ortho clinical diagnostics inc (ortho). Complaint numbers (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007111389-2019-00092 |
| MDR Report Key | 8645359 |
| Date Received | 2019-05-28 |
| Date of Report | 2019-05-28 |
| Date of Event | 2018-09-20 |
| Date Mfgr Received | 2019-05-02 |
| Device Manufacturer Date | 2018-03-15 |
| Date Added to Maude | 2019-05-28 |
| 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 INTACT PTH REAGENT PACK |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | CEW |
| Date Received | 2019-05-28 |
| Catalog Number | 6802892 |
| Lot Number | 0930 |
| Device Expiration Date | 2018-11-26 |
| 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 | 2019-05-28 |