MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-07-20 for ADVIA CHEMISTRY CARBON DIOXIDE REAGENT, CONCENTRATED (CO2_C) 10283345 manufactured by Siemens Healthcare Diagnostics Inc..
[114547047]
The customer contacted a siemens customer care center. Quality controls (qc) on the morning of event occurrence were acceptable. The customer noticed that the patient samples were elevated. The customer ran qc and found that the results were out of range high. The customer performed assay calibration, which failed. The reagent blank tracking was also failing. The customer ran qc for other assays, which were acceptable. The customer installed a new reagent wedge of the same kit lot and ran calibration and qc, which were acceptable. The issue was resolved with the replacement of reagent wedge. The device is performing within manufacturing specifications. No further evaluation of device is required.
Patient Sequence No: 1, Text Type: N, H10
[114547048]
Discordant, falsely elevated carbon dioxide, concentrated (co2_c) results were obtained on multiple patient samples on an advia 1800 instrument, while using reagent lot 010. The initial results for ten patient samples were reported to the physician(s). The discordant results for the rest of the patient samples were not reported to the physician(s). After replacing the reagent wedge, the samples were repeated on the same instrument, resulting lower. The corrected results for five of ten patient samples were reported to the physician(s), as the discordant results for those samples were initially reported. It is unknown if the other five samples repeated same. The repeat results were reported for the rest of the samples. There are no reports of patient intervention or adverse health consequence due to the discordant, falsely elevated co2_c results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2018-00302 |
| MDR Report Key | 7705894 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-07-20 |
| Date of Report | 2018-07-24 |
| Date of Event | 2018-06-26 |
| Date Mfgr Received | 2018-07-23 |
| Date Added to Maude | 2018-07-20 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SHWETA GULATI |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242870 |
| Manufacturer G1 | SEKISUI DIAGNOSTICS PEI INC. |
| Manufacturer Street | REGISTRATION # 8020316 70 WATTS AVENUE |
| Manufacturer City | CHARLOTTETOWN, PE C1E 2B9 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | C1E 2B9 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CHEMISTRY CARBON DIOXIDE REAGENT, CONCENTRATED (CO2_C) |
| Generic Name | ADVIA CHEMISTRY CARBON DIOXIDE REAGENT, CONCENTRATED (CO2_C) |
| Product Code | KHS |
| Date Received | 2018-07-20 |
| Model Number | ADVIA CHEMISTRY CARBON DIOXIDE REAGENT, CONCENTRAT |
| Catalog Number | 10283345 |
| Lot Number | 010 |
| Device Expiration Date | 2019-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 511 BENEDICT AVE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-20 |