MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-15 for VITROS CHEMISTRY PRODUCTS DGXN SLIDES 8343386 manufactured by Ortho-clinical Diagnostics.
[70325287]
The investigation determined that lower than expected vitros dgxn patient results were obtained on a vitros 5600 integrated system. The assignable cause for the event is unknown. An issue with vitros dgxn reagent lot 1911-0240-6317 or the vitros 5600 system cannot be completely ruled out as contributing factors to the event. In addition, improper pre-analytical sample processing (centrifugation) is a possible contributing factor to the event. The customer is not centrifuging the samples in accordance with the sample collection device manufacturer's recommendations and improper pre-analytical sample handling cannot be ruled out as contributing to the event. It is possible that cellular debris, due to poor sample preparation, was present in the affected samples, although this could not be confirmed. No information was provided regarding the patient? S medication, therefore, a possible interferent cannot be ruled out as a contributing factor.
Patient Sequence No: 1, Text Type: N, H10
[70325288]
A customer observed lower than expected vitros dgxn results from 2 samples from the same patient obtained on a vitros 5600 integrated system. Patient sample 1 result of 1. 9 ng/ml vs. The expected result of 2. 65 ng/ml. Patient sample 2 result of 1. 4 ng/ml vs. The expected result of 2. 04 ng/ml. This report is number one of two mdr? S for this event. Two 3500a forms are being submitted for this event as two devices were involved. The lower than expected results were not reported outside of the laboratory, and there were no allegations of patient harm. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319809-2017-00020 |
| MDR Report Key | 6408200 |
| Date Received | 2017-03-15 |
| Date of Report | 2017-03-15 |
| Date of Event | 2017-01-26 |
| Date Mfgr Received | 2017-02-15 |
| Device Manufacturer Date | 2016-10-25 |
| Date Added to Maude | 2017-03-15 |
| 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 | 513 TECHNOLOGY BLVD. |
| Manufacturer City | ROCHESTER NY 14652 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14652 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VITROS CHEMISTRY PRODUCTS DGXN SLIDES |
| Generic Name | IN VITRO DIAGNOSTIC |
| Product Code | LFM |
| Date Received | 2017-03-15 |
| Catalog Number | 8343386 |
| Lot Number | 1911-0240-6317 |
| ID Number | 10758750004782 |
| Device Expiration Date | 2017-03-15 |
| 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 | 2017-03-15 |