MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-18 for ARCHITECT STAT CK-MB 02K42-28 manufactured by Abbott Laboratories.
[98074001]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[98074002]
The customer reported falsely elevated architect stat ck-mb results for two patients. The first patient (sample id (b)(6)) generated a ck-mb result of 32. 0 ng/ml. A new sample ((b)(6)) drawn 3 hours later generated a ck-mb of 2. 0 ng/ml. The second patient (sample id (b)(6)) generated a ck-mb result of 17. 9 ng/ml and retest (sid (b)(6)) 2. 3 ng/ml. A second sample drawn 3 hours later (sid (b)(6)) generated a ck-mb result of 2. 2 ng/ml and retest (sid (b)(6)) 2. 3 ng/ml. No specific patient information was provided and no adverse impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1415939-2018-00004 |
| MDR Report Key | 7203536 |
| Date Received | 2018-01-18 |
| Date of Report | 2018-02-12 |
| Date Mfgr Received | 2018-02-07 |
| Device Manufacturer Date | 2017-04-01 |
| Date Added to Maude | 2018-01-18 |
| 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 LABORATORIES |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 600643500 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 600643500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ARCHITECT STAT CK-MB |
| Generic Name | CK-MB |
| Product Code | JHX |
| Date Received | 2018-01-18 |
| Catalog Number | 02K42-28 |
| Lot Number | 79350UN17 |
| Device Expiration Date | 2018-09-30 |
| 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 LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK ROAD ABBOTT PARK IL 600643500 US 600643500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-18 |