MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-12-20 for NUCLISENS? LYSIS BUFFER 200292 manufactured by Biomerieux Sa.
[62914096]
A customer from (b)(6) reported to biom? Rieux a product performance problem in association with nuclisens? Lysis buffer. The test eluates were colored for several whole blood extractions. There was no protocol change or buffer change since the beginning of the week. Repeat testing also produced color eluates. The customer tested the colored eluates and was not able to communicate results because the samples were inhibited. The customer indicated testing two series in adenovirus, bk and hhv6 eurobio kits and the 2 internal kits were with all samples. The customer reported there was a 24 hour delay in obtaining results and one patient was not able to provide another sample for retesting so no results were produced. No results were reported to the physician and there was no impact to patients or their treatment. A biom? Rieux internal investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5
[73852532]
A customer from france reported to biom? Rieux a problem with discoloration of test eluates for several whole blood extractions in association with nuclisens? Lysis buffer. An investigation was conducted. The investigation confirmed the customer issue. The eluate becomes colored because of the presence of hemoglobin in blood samples. The presence of hemoglobin can cause the inhibition of downstream applications (pcr, rt pcr, nasba etc. ), resulting in uninterpretable test results. If an internal control is used, as it is recommended for molecular tests, it would be inhibited thereby invalidating the test. If the internal control would not be inhibited or not used at all, the tests run with colored eluates could potentially result in false negative results. The root cause of the coloration has been confirmed to be linked to a non-conforming ph value for batch 16092902. It has been measured at 6. 9 instead of 7. 1 +/ -0. 1 as per product specification. The origin of the ph non-conformity has been identified and additional tests and precautions have been already put in place to avoid this issue in the future. The investigation confirmed that no other lots of nuclisens? Lysis buffer (ref 200292), or any other nuclisens? Extraction reagent available in the field, have been impacted by the same ph non-conformance. The ph issue was also checked for an impact on other matrices, even if the inhibition is due to the hemoglobin. Dry blood spot (containing hemoglobin) and stools were tested which confirmed the issue can happen for the dry blood spot but not for the stools. The investigation confirmed the customer complaint and corrective and preventative actions are being implemented into the manufacturing process. A field safety corrective action was issued as fsca 3337- nuclisens lysis buf - ref 200292_lot 16092902_colored eluates exhibiting pcr inhibition published the 08mar2017.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00521 |
| MDR Report Key | 6190572 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-12-20 |
| Date of Report | 2017-04-13 |
| Date Mfgr Received | 2017-03-16 |
| Date Added to Maude | 2016-12-20 |
| 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 | BIOMERIEUX SA |
| Manufacturer Street | CHEMIN DE L ORME |
| Manufacturer City | MARCY L ETOILE, RHONE 69280 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 69280 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUCLISENS? LYSIS BUFFER |
| Generic Name | NUCLISENS? LYSIS BUFFER |
| Product Code | LDT |
| Date Received | 2016-12-20 |
| Catalog Number | 200292 |
| Lot Number | 16092902 |
| Device Expiration Date | 2018-08-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX SA |
| Manufacturer Address | 5 RUE DE BERGES GRENOBLE, CEDDEX 01 38024 FR 38024 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-20 |