MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-05-12 for VITROS CHEMISTRY PRODUCTS AMON SLIDES 1721869 manufactured by Ortho-clinical Diagnostics.
[5798044]
The customer complained that lower and higher than expected vitros amon results were obtained from two different levels of non-vitros biorad controls and a single level of vitros lpv fluid tested on a vitros 350 chemistry system. Biorad l2 results: 126. 1, 82. 2, 64. 5, 80. 2, 79. 9, 82. 8, 68. 2, 49. 8, 79. 4, 52. 7, 59. 0, 79. 9, 57. 1, 51. 9, 71. 1, 70. 6, 73. 6, 64. 7, 77. 9, and 126. 4 umol/l vs expected result 104. 5 umol/l biorad l3 results: 196. 4, 197. 7, and 203. 4 umol/l vs expected result 262. 6 umol/l. Vitros lpv l3179 result: 235 umol/l compared to an expected result of 189. 2 umol/l. Biased results of the direction and magnitude observed may lead to inappropriate physician action. No vitros amon patient sample results were questioned during the timeframe of the events; however, the investigation cannot conclude that patient sample results were not or could not be affected if the event were to recur undetected. There was no reported allegation of patient harm as a result of these events. This report is number three of twenty-four mdr? S for this event. Twenty-four 3500a forms are being submitted for this event as twenty-four devices were involved. This report corresponds to ortho clinical diagnostics inc. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[13357333]
The investigation determined that lower and higher than expected vitros amon results were obtained from two different levels of non-vitros biorad controls and a single level of vitros lpv fluid tested on a vitros 350 chemistry system. The assignable cause of the events is unknown; however, an unknown issue related to the vitros amon slides or improper pre-analytical fluid handling protocol cannot be ruled out as contributing to the events. The investigation found no indication the vitros 350 chemistry system malfunctioned. The investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319809-2015-00046 |
| MDR Report Key | 4766051 |
| Report Source | 05 |
| Date Received | 2015-05-12 |
| Date of Report | 2015-05-12 |
| Date of Event | 2015-04-01 |
| Date Mfgr Received | 2015-04-17 |
| Device Manufacturer Date | 2014-05-12 |
| Date Added to Maude | 2015-06-09 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| 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 | 3 |
| Brand Name | VITROS CHEMISTRY PRODUCTS AMON SLIDES |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | JID |
| Date Received | 2015-05-12 |
| Catalog Number | 1721869 |
| Lot Number | 1014-0234-3725 |
| Device Expiration Date | 2015-08-01 |
| 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 | 2015-05-12 |