MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-11 for ALINITY C CARBON DIOXIDE 07P72-20 manufactured by Abbott Germany.
[141935729]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. There is no further patient information provided by the customer.
Patient Sequence No: 1, Text Type: N, H10
[141935730]
The customer reported falsely elevated co2 results on 6 patients on the alinity c analyzer. The results provided were: pt#1 = 36 meq/l/ 19; pt#2 = 42 / 29; pt#3 = 37 /24; pt#4 = 33 /23; pt#5 = 41 / 29; pt#6 = 36 /25 (normal range 21-32meq/l). There was no reported impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002809144-2019-00194 |
| MDR Report Key | 8504151 |
| Date Received | 2019-04-11 |
| Date of Report | 2019-05-29 |
| Date of Event | 2019-03-20 |
| Date Mfgr Received | 2019-05-16 |
| Device Manufacturer Date | 2018-06-22 |
| Date Added to Maude | 2019-04-11 |
| 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 | NOEMI ROMERO-KONDOS, RN BSN |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 224667-512 |
| Manufacturer G1 | ABBOTT GERMANY |
| Manufacturer Street | MAX-PLANCK-RING 2 |
| Manufacturer City | WIESBADEN 65205 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 65205 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ALINITY C CARBON DIOXIDE |
| Generic Name | CARBON DIOXIDE |
| Product Code | KHS |
| Date Received | 2019-04-11 |
| Catalog Number | 07P72-20 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT GERMANY |
| Manufacturer Address | MAX-PLANCK-RING 2 WIESBADEN 65205 GM 65205 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-11 |