MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-07-09 for CLINICAL CHEMISTRY CARBON DIOXIDE 03L80-21 manufactured by Abbott Manufacturing Inc.
[113515161]
This issue was previously reported under mdr number 1415939-2018-00108 for the incorrect manufacturer: abbott laboratories, (b)(4), usa. This submission corrects the manufacturer. An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. Complete information for section a. Patient information, 1. Patient identifier: multiple = sid (b)(6). There is no further patient information obtained from the customer.
Patient Sequence No: 1, Text Type: N, H10
[113515162]
The customer reported falsely elevated co2 results on multiple patients. The results provided were for 5 samples: sid (b)(6) = 33. 27 / 24. 67; sid (b)(6) = 31. 89 / 24. 26; sid (b)(6) = 31. 75 / 23. 68; sid (b)(6) = 32. 47 / 24. 67; sid (b)(6) = 32. 87 / 24. 52. There was no reported impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2018-00265 |
| MDR Report Key | 7671710 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-07-09 |
| Date of Report | 2018-09-05 |
| Date Mfgr Received | 2018-08-17 |
| Device Manufacturer Date | 2017-10-11 |
| Date Added to Maude | 2018-07-09 |
| 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 MANUFACTURING INC |
| Manufacturer Street | 1921 HURD DRIVE |
| Manufacturer City | IRVING TX 750383500 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 750383500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINICAL CHEMISTRY CARBON DIOXIDE |
| Generic Name | CARBON DIOXIDE |
| Product Code | KHS |
| Date Received | 2018-07-09 |
| Catalog Number | 03L80-21 |
| Lot Number | 51686UQ08 |
| Device Expiration Date | 2018-09-30 |
| 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 MANUFACTURING INC |
| Manufacturer Address | 1921 HURD DRIVE IRVING TX 750383500 US 750383500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-09 |