MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-12 for VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK 1849793 manufactured by Ortho-clinical Diagnostics.
[112042409]
The investigation determined a lower than expected vitros tsh result was obtained when processing a patient sample on a vitros 5600 system when compared to a non-vitros beckman tsh result. Additionally lower than expected fsh, lh, prol and higher than expected cort and testosterone (testo) results were also obtained from the same patient. The most likely assignable cause of the event is biotin interference. The patient was taking a daily biotin supplement of 5. 0 mg/day. Vitros tsh, fsh, lh, prol, cort, or testo assays are susceptible to biotin interference. Non-vitros tsh, prol, cort, and testo results obtained from methods not affected by biotin interference generated expected results from the patient samples. In addition, vitros fsh, lh, prol and testo results were closer to the expected results 2 days after the patient discontinued taking the biotin supplements, when the biotin was starting to clear from the patients system. Ortho previously issued a customer letter? Information on how biotin may affect specific vitros microwell assays? To alert customers of the effect high-dose biotin supplements have on some vitros immunodiagnostics products (microwell assays) such as the vitros tsh, fsh, lh, prol, cort, or testo assays. These vitros assays include the use of streptavidin-biotin in the design which may be susceptible to biotin interference. Therefore, the biotin in the samples is a potential interfering substance and cannot be ruled out as contributing to the event.
Patient Sequence No: 1, Text Type: N, H10
[112042410]
An article published in journal of the endocrine society (jes), a peer-reviewed medical journal published monthly by the endocrine society. (suspected testosterone-producing tumor in a patient taking biotin supplements (jes. 2018) doi/10. 1210/js. 2018-00069/4994589) documented a case study involving a (b)(6) woman presented to the endocrinology clinic with palpitations, inability to lose weight and hirsutism. The referring provider questioned whether these symptoms might be related to the patient? S known thyroid dysfunction, subclinical hyperthyroidism, previously diagnosed. The patient was taking a daily biotin supplement of 5. 0 mg/day. A lower than expected vitros tsh result was obtained from a patient sample tested on a vitros 5600 system when compared to a non-vitros beckman tsh result which is not susceptible to biotin interference. Patient sample vitros tsh results of 0. 06 miu/l vs. The expected tsh result of 1. 1 miu/l biased tsh results of the direction and magnitude observed could lead to inappropriate physician action. Additionally, based on lower than expected vitros prolactin (prol) and higher than expected vitros cortisol (cort) results, the patient underwent a ct scan and mri. Based on medical consultations with the ortho medical safety officer, serious long term health impact from the mri or ct procedures is not anticipated. Ortho was not made aware of any allegation of actual patient harm due to the event. This report is number three of three mdr? S for this event. Three 3500a forms are being submitted for this event as three devices were involved. This report corresponds to ortho clinical diagnostics inc. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007111389-2018-00085 |
| MDR Report Key | 7594342 |
| Date Received | 2018-06-12 |
| Date of Report | 2018-06-12 |
| Date of Event | 2018-05-15 |
| Date Mfgr Received | 2018-05-15 |
| Date Added to Maude | 2018-06-12 |
| 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 PROLACTIN REAGENT PACK |
| Generic Name | IN VITRO DIAGNOSTIC |
| Product Code | CFT |
| Date Received | 2018-06-12 |
| Catalog Number | 1849793 |
| Lot Number | NOT PROVIDED |
| ID Number | 10758750000111 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Other | 2018-06-12 |