MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-24 for ARCHITECT C4000 ANALYZER 02P24-40 manufactured by Abbott Manufacturing Inc.
[34936717]
(b)(4). A followup report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[34936718]
The account stated 2 patient samples generated elevated architect co2 results when processing on the pm shift that were repeated on the am shift with lower values. Id (b)(6) generated elevated architect co2 of 31. 5 meq/l but repeated 23. 3 meq/l. Id (b)(6) generated elevated architect co2 of 31. 9 meq/l but repeated 23. 5 meq/l. The account uses a reference range of 22 to 29 meq/l (19 to 59 years old) and 23 to 31 meq/l (60 years old and above). No specific patient information was provided. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
[36866879]
Additional specific patient information was provided. Sample id (b)(6) is a female with date of birth 1986. Sample id (b)(6) is a female with date of birth 1974. Evaluation in process.
Patient Sequence No: 1, Text Type: N, H10
[38096192]
After further evaluation, the suspect medical device was changed from architect c4000, list 02p24-40, manufacturing site (b)(6), to carbon dioxide, list 03l80-21, manufacturing site (b)(6). Mdr number 1415939-2016-00024 has been submitted and all further information will be documented under that mdr number.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2015-00337 |
| MDR Report Key | 5326480 |
| Date Received | 2015-12-24 |
| Date of Report | 2016-02-11 |
| Date of Event | 2015-12-02 |
| Date Mfgr Received | 2016-01-15 |
| Date Added to Maude | 2015-12-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 75038 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75038 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT C4000 ANALYZER |
| Generic Name | AUTOMATED CHEMISTRY ANALYZER |
| Product Code | CHS |
| Date Received | 2015-12-24 |
| Catalog Number | 02P24-40 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MANUFACTURING INC |
| Manufacturer Address | 1921 HURD DRIVE IRVING TX 75038 US 75038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-24 |