MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-04-25 for ALINITY C CO2 07P72-20 manufactured by Abbott Germany.
[143841268]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. Patient information: no specific patient information was provided by the customer.
Patient Sequence No: 1, Text Type: N, H10
[143841269]
The customer reported a falsely elevated alinity co2 result. Sample id (b)(6) generated 31. 7 mmol/l and retest 25. 9 mmol/l. The customer uses a normal range of 22 to 29 mmol/l (meq/l). No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002809144-2019-00247 |
| MDR Report Key | 8551864 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-04-25 |
| Date of Report | 2019-11-05 |
| Date of Event | 2019-03-27 |
| Date Mfgr Received | 2019-11-04 |
| Device Manufacturer Date | 2018-06-22 |
| Date Added to Maude | 2019-04-25 |
| 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 | CHRISTIAN LEE |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT 09B9, BLDG CP01-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 224668-294 |
| 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 |
| Removal Correction Number | 3002809144-10/24/19-009R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALINITY C CO2 |
| Generic Name | CARBON DIOXIDE |
| Product Code | KHS |
| Date Received | 2019-04-25 |
| Catalog Number | 07P72-20 |
| Lot Number | 53069UQ05 |
| Device Expiration Date | 2019-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-04-25 |