MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-11-03 for AXSYM ETHANOL REAGENT 03B32-20 manufactured by Abbott Laboratories.
[9590492]
The evaluation began with accuracy testing using likely cause axsym ethanol reagent lot 08551m500. Testing met all acceptance criteria. A review of information from the customer site regarding a visit from the abbott field service representative found that the axsym plus analyzer is operating as expected and the customer's issue was most likely due to the integrity of the samples involved. No reoccurrence of the issue has been seen. A review of complaint tracking and trending metrics was performed and identified no adverse trends in conjunction with the complaint issue currently under evaluation. The axsym rea ethanol assay package insert contains information regarding sample handling procedures to address the customer's current issue. Based on the results of the current evaluation, the axsym rea ethanol reagent lot 08551m500 is performing as intended and no additional product issues were identified. No further investigation is required.
Patient Sequence No: 1, Text Type: N, H10
[21407758]
The customer states that one patient sample generated an initial axsym ethanol assay result of 5. 101 mg/dl. The result did not fit the patient's clinical condition and the sample was retested. The retest result was 176. 77 mg/dl, which corresponded to the patient's condition and this result was reported from the lab. There is no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[21516587]
An investigation is in process. A follow-up report will be submitted when the investigation is complete. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2011-00679 |
| MDR Report Key | 2323510 |
| Report Source | 05 |
| Date Received | 2011-11-03 |
| Date of Report | 2011-11-02 |
| Date of Event | 2011-11-02 |
| Date Mfgr Received | 2012-01-27 |
| Device Manufacturer Date | 2011-10-01 |
| Date Added to Maude | 2012-05-21 |
| 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 | 0 |
| Event Location | 0 |
| 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 | 847937-512 |
| Manufacturer G1 | ABBOTT LABORATORIES |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 60064350 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60064 3500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AXSYM ETHANOL REAGENT |
| Product Code | DML |
| Date Received | 2011-11-03 |
| Catalog Number | 03B32-20 |
| Lot Number | 08551M500 |
| Device Expiration Date | 2012-04-12 |
| 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 60064350 US 60064 3500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-03 |