MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2020-03-10 for VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK 1912997 manufactured by Ortho-clinical Diagnostics.
[188237912]
The investigation concluded that lower than expected vitros tsh results were obtained from two samples obtained from the same patient processed on two different tsh reagent lots using a vitros 5600 integrated system and a vitros xt 7600 integrated system. The most likely assignable cause of the lower than expected vitros tsh results is the presence of a sample interferent that affects the vitros tsh assay. One of patient samples was processed neat and then diluted using 3 different dilution factors prior to repeat testing. The tsh results obtained from the diluted samples were aligned with the results obtained from the non-vitros methods suggesting there is an interferent (heterophilic antibody, biotin interference, drug or secondary metabolite) in the patient samples that was minimized with dilution. There was no indication of an issue with the vitros 5600 or the xt 7600 analyzers and an instrument issue is not a likely contributor to this event. In addition, a review of historical tsh lot 6060 quality control data indicates the reagent was performing as expected. There was no tsh qc data provided from the vitros xt 7600 analyzer in combination with tsh lot 6000 to definitively confirm the performance of the reagent. However, there was no indication from the customer of a performance concern with tsh lot 6000. In addition, ongoing tracking and trending of complaint data has not identified any signals to suggest a systemic quality issue with vitros tsh lot 6060 or lot 6000 and therefore, a vitros tsh reagent issue has been ruled out as a contributor to the event.
Patient Sequence No: 1, Text Type: N, H10
[188237913]
A customer contacted the ortho clinical diagnostics (ortho) technical solutions center (tsc) to report lower than expected tsh results obtained from patient samples using vitros tsh reagent on a vitros 5600 integrated system and a vitros xt 7600 integrated system, when compared to tsh results obtained from using a non-vitros system. Vitros tsh lot 6060 = 12. 0, 12. 8, 30. 9 versus expected >100 miu/l. Vitros tsh lot 6000 = 53. 6 versus expected >100 miu/l. Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples. The lower than expected tsh result 12. 0 miu/l was reported from the laboratory. The patient was at the hospital for a kidney transplant. The patient was not satisfied with the two different reports of tsh within 2 days and raised a complaint to the hospital authorities. The patient no longer wanted to get the kidney transplant at this hospital, requested discharge and moved to other hospital. There were no allegations of patient harm as a result of the event. This report is number 2 of 2 mdr? S for this event. Two (2) 3500a forms are being submitted for this event as 2 devices were involved. This report corresponds to ortho clinical diagnostics inc. Complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007111389-2020-00026 |
| MDR Report Key | 9813373 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-02-10 |
| Date Mfgr Received | 2020-02-11 |
| Device Manufacturer Date | 2019-08-20 |
| Date Added to Maude | 2020-03-10 |
| 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 | 3 |
| Brand Name | VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK |
| Generic Name | IN VITRO DIAGNOSTICS |
| Product Code | JLW |
| Date Received | 2020-03-10 |
| Catalog Number | 1912997 |
| Lot Number | 6000 |
| 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 | 2020-03-10 |