MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-11-26 for NEOBASE NON-DERIVATIZED MSMS KIT 3040-001U manufactured by Wallac Oy.
[3045785]
Three customer complaints have been received; 3 in (b)(6) 2012 and 1 in (b)(6) 2012. The complaints alleged empty microplate wells were observed after the extraction incubation step when using neobase non-derivatized msms kit. The complaints were from, (b)(6), u. S about neobase product lot 618494 (received on (b)(6) 2012), (b)(6), u. S about neobase product lot 617253 (received (b)(6) 2012), (b)(6) about neobase product lot 618763 (received (b)(6) 2012). All three complaints alleged occasional dry or empty wells after the extraction incubation step of the neobase assay. The result is that the testing could not be continued / completed. No false negative or false positive results are known to have been reported. Defects in the 96-well truncated v-bottomed microplate is the issue. The microplate is a consumable provided with the neobase kit. The same plate is used also with other product as consumable.
Patient Sequence No: 1, Text Type: D, B5
[10337226]
Lot # 618763, manufacture date: 06/2012. The truncated v-bottomed microplate has exhibited defects; presenting as hole(s) or crack(s) in the bottom of some wells. During the extraction incubation step of affected assays, the extraction solution leaks from the wells leaving the well empty almost empty or with a usable volume of solution. This may result in the following scenarios occurring. Scenario 1: when leakage occurs, in approximately 80% of the occurrences the result is an empty or near empty well after the incubation. The test cannot physically proceed due to the lack of solution. In this scenario the sample must be repeated. The delay experienced is a delay in the reporting of the results. Scenario 2: after first incubation the well has sufficient solution remaining in the well to physically proceed with testing, however the solution is decreased in volume from the expected amount routinely present after incubation. In this scenario the sample concentration measured may be falsely low or high and in the worst case result in false negative screening result to be reported. The reporting of a false negative screening interpretation results may delay the diagnosis of the disorder. Depending on the severity of the disorder the false negative may result in serious deterioration of the newborn's health. Based on the noticed frequency of defective wells, the theoretical probability of false negative reported is estimated to be 0. 00001% - 0. 0003% depending on the incidence rate of the disorder.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8043909-2012-00002 |
| MDR Report Key | 2850407 |
| Report Source | 05 |
| Date Received | 2012-11-26 |
| Date of Report | 2012-11-26 |
| Date of Event | 2012-10-12 |
| Date Mfgr Received | 2012-10-12 |
| Device Manufacturer Date | 2012-08-01 |
| Date Added to Maude | 2013-03-04 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ANN-CHRISTINE FAGERSTROM, DIRECTOR |
| Manufacturer Street | MUSTIONKATU 6 |
| Manufacturer City | TURKU FI-20101 |
| Manufacturer Country | FI |
| Manufacturer Postal | FI-20101 |
| Manufacturer Phone | 3582267812 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEOBASE NON-DERIVATIZED MSMS KIT |
| Product Code | NQL |
| Date Received | 2012-11-26 |
| Returned To Mfg | 2012-10-29 |
| Model Number | 3040-001U |
| Lot Number | 618494 |
| ID Number | 617253 APR2013 |
| Device Expiration Date | 2013-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WALLAC OY |
| Manufacturer Address | TURKU FI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-11-26 |