MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-09-14 for VIDAS? ANALYZER 410417 manufactured by Biom?rieux Italia.
[54766209]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[54766210]
A customer in (b)(6) contacted biom? Rieux to report a qcv (quality control verification) failure (section a1) in association with the vidas analyzer. The qcv was performed in response to physicians stating unexpected tnsh results were reported for patients. The local field service engineer (fse) visited the customer site and performed service in the way of pump cleaning and seal replacement. The failure continued to occur; replacement pump was necessary. Following pump replacement, the qcv test passes. All other sections were also confirmed to be functioning properly. Biom? Rieux advised the customer to perform a retrospective analysis to the last successful qcv test. The customer stated there has been no impact to patient treatment. There is no indication or report from the laboratory that the failed qcv and/or recommended retrospective analysis identified any adverse event related to any patient's state of health. Biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[63834048]
A customer in (b)(6) contacted biom? Rieux to report a qcv (quality control verification) failure in association with the vidas? Analyzer. An internal biom? Rieux investigation was performed. The customer reported to biom? Rieux that unexpected tnsh results were reported for patients by the physician and tnsh calibration value was out of range in slot a1 with vidas? Analyzer eu (s/n: (b)(4)). The field service engineer (fse) confirmed the problem by performing a qcv three (3) times, which showed a very low value tv1 all three (3) times. The last conform qcv was performed on this instrument on 24jun2016. The last preventive maintenance was performed on this instrument on 09jun2016. After the qcv failure, the customer stopped using the section a of the instrument and performed a retrospective analysis between the last conform qcv (24jun2016) and the failed one (15jul2016). Retrospective analysis performed on the position a1 during the relevant period determined two (20 patient samples may have been affected (note: one sample tested twice). Root cause: the qcv failure detected in section a slot 1 highlighted a possible clog issue in this position. Observation of a qcv failure is not an abnormal behavior but means the qcv performed as a functional control. This control is meant to detect residual risks, that are rare and sudden. Those risks are already present and accepted into the vidas? Systems risk analysis. The vidas? Pump tester is used to validate or invalidate the presence of a clog in the pump tested. As the result value of the vidas? Pump tester in section a slot 1 was not conform, the root cause was determined to be a clog in the slot 1 of the pump in section a. Reparation - qualification of the instrument: as the clog was confirmed, the fse cleaned the six (6) slots of the section a pump with the pump cleaner and replaced the dirty seals. After the cleaning, the fse performed a new pump tester on the section a. The result value in the section a slot 1 was still not conform; therefore, the fse then replaced the section a pump assembly and performed all needed adjustments. After the replacement, the fse qualified the instrument by performing a leak test on the section a of the instrument. The result values of the leak test were conform for the six (6) slots of section a. The instrument was qualified by performing a leak test at the end of the intervention and result values were all conform on all slots of section a retrospective analysis: as requested by biom? Rieux, the customer performed a retrospective analysis for tests that were performed on slot 1 of section a of the instrument from the 24jun2016 (date of the last conform qcv) to 15jul2016 (date of the qcv failure). The retrospective analysis showed that two (2) patient samples that were run on section a slot 1 were affected (note: one sample tested twice). As detailed in the retrospective analysis document, for the two (2) patient samples, there was no consequence on the treatment (inappropriate or delayed treatment) and no clinical consequences due to false result (e. G. Hospitalization, delayed or wrong diagnosis, death or injury).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00254 |
| MDR Report Key | 5950881 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-09-14 |
| Date of Report | 2016-07-15 |
| Date Mfgr Received | 2016-07-15 |
| Date Added to Maude | 2016-09-14 |
| 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 | MRS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317301 |
| Manufacturer G1 | BIOM |
| Manufacturer Street | VIA DI CAMPIGLIANO 58 PONTE-A EMA |
| Manufacturer City | FIRENZE, ITALY 50015 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 50015 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIDAS? ANALYZER |
| Generic Name | VIDAS? ANALYZER |
| Product Code | DEW |
| Date Received | 2016-09-14 |
| Model Number | 410417 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOM?RIEUX ITALIA |
| Manufacturer Address | VIA DI CAMPIGLIANO 58 PONTE-A EMA FIRENZE, ITALY 50015 IT 50015 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-14 |