MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-01-16 for VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK 6801042 manufactured by Ortho-clinical Diagnostics.
[4058726]
The customer observed lower than expected vitros myog results (sample 1 = 1,223, sample 2 = 1,520, sample 3 = 1,730, sample 4 = 1,651, sample 5 = 1,984 ng/ml) for multiple samples drawn from the same patient. The issue was observed across two different vitros 5600 integrated systems. The lower than expected results were initially reported to a physician. Once the issue was identified, repeat testing was performed using a sample dilution and expected vitros myog results (sample 1 = >200,000, sample 2 = >200,000, sample 3 = 195,367, sample 4 = 194,888, sample 5 = 164,996 ng/ml) were obtained. A corrected report was issued for the patient in question based on the repeat testing. The physician alleged that patient treatment was mis-managed based on the lower than expected vitros myog results initially reported. In particular, dialysis treatment was delayed until the time that the corrected vitros myog report was issued. The potential for patient harm in this scenario due to a delay in initiating dialysis treatment cannot be ruled out. However, there was no report of actual harm to the patient as a result of this event. This report corresponds to ortho clinical diagnostics inc. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11417578]
Lower than expected vitros myog results were obtained for multiple samples drawn from the same patient. The investigation determined that the most likely cause of the event is a limitation of the vitros myog reagent relating to a high dose hook effect. Per the vitros myog instructions for use (version 4. 0), the assay measuring range is 0. 9 - 2,000 ng/ml and the assay has no high dose hook effect up to 100,000 ng/ml. Based on the repeat testing performed using sample dilutions, the expected vitros myog result for each patient sample exceeded 100,000 ng/ml. Therefore, the vitros myog reagent was performing within claims. There was no malfunction of the vitros 5600 integrated systems or the vitros myog reagent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007111389-2014-00007 |
| MDR Report Key | 3579733 |
| Report Source | 05 |
| Date Received | 2014-01-16 |
| Date of Report | 2014-01-16 |
| Date of Event | 2013-12-18 |
| Date Mfgr Received | 2013-12-19 |
| Device Manufacturer Date | 2013-07-15 |
| Date Added to Maude | 2014-01-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. JOSEPH FALVO |
| 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 MYOGLOBIN REAGENT PACK |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | DDR |
| Date Received | 2014-01-16 |
| Catalog Number | 6801042 |
| Lot Number | 0900 |
| Device Expiration Date | 2014-06-11 |
| 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 | 2014-01-16 |