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 2018-08-14 for ENZYMATIC CARBONATE FLEX REAGENT CARTRIDGE 10444972 manufactured by Siemens Healthcare Diagnostics Inc..
[117446512]
The customer contacted a siemens customer care center (ccc) and reported that reagent arm 1 probe and reagent lot were replaced on the dimension exl 200 instrument due to the discordant eco2 results. The customer reported that after replacing the reagent and probe, calibration and quality controls (qcs) were acceptable. The customer indicated that the reagent used in initial testing was compromised, and resolved the issue by replacing the reagent. A siemens customer service engineer (cse) was dispatched to the customer site to collect data for further analysis. Siemens further analyzed the instrument files and determined that qc was within range and there were no additional discordant results obtained on the instrument using the enzymatic carbonate flex reagent cartridge. The cause of the discordant, falsely elevated eco2 results is unknown. The instrument and reagent are operating within manufacturing specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[117446513]
Discordant, falsely elevated enzymatic carbonate (eco2) results were obtained on three patient samples on a dimension exl 200 instrument using the enzymatic carbonate flex reagent cartridge lot eb9122. The customer replaced reagent arm 1 probe and repeated two samples, resulting in two discordant, falsely elevated eco2 results. The discordant results were not reported to the physician(s). Using a new reagent from lot eb9122, the samples were repeated on the same instrument, resulting lower. The 2nd repeat results were reported, as the correct results, to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated eco2 results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2018-00453 |
| MDR Report Key | 7782805 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-08-14 |
| Date of Report | 2018-08-14 |
| Date of Event | 2018-07-19 |
| Date Mfgr Received | 2018-07-19 |
| Date Added to Maude | 2018-08-14 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. ANU PRASAD |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242530 |
| Manufacturer G1 | SIEMENS HEATLHCARE DIAGNOSTICS INC. |
| Manufacturer Street | 500 GBC DRIVE PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 197146101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENZYMATIC CARBONATE FLEX REAGENT CARTRIDGE |
| Generic Name | ENZYMATIC CARBONATE FLEX REAGENT CARTRIDGE |
| Product Code | KHS |
| Date Received | 2018-08-14 |
| Catalog Number | 10444972 |
| Lot Number | EB9122 |
| Device Expiration Date | 2019-05-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-14 |