MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-23 for ARCHITECT CYCLOSPORINE 01L75-25 manufactured by Abbott Laboratories.
[45811707]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[45811708]
The customer reports that one patient's architect cyclosporine assay result of 717ng/ml (sid (b)(4)) was questioned by a staff nurse as the previous result for this patient was 307 ng/ml. The sample was retested the following day and generated a result of 237 ng/ml. A new sample was drawn (sid (b)(4)) and generated a result of 42 ng/ml. The customer commented that the staff nurse felt this result was too low. Controls have remained within specifications. There is no reported adverse impact to patient care due to this issue. Upon troubleshooting it was discovered that the precipitation solution the customer was using (list 01l75-55, lot 524888) had expired (30 march 2016). Css advised the customer to open a new in date bottle of solution and retest all samples. Upon retest of the samples using in date precipitation solution, results were similar to those generated with the expired precipitation solution (units of measure = ng/ml): 47. 17 (expired) retest 56. 80 (in-date); 230. 96 (expired) retest 234. 62 (in-date); 237. 28 (expired) retest 239. 89 (in-date). There is no reported impact to patient care due to this issue.
Patient Sequence No: 1, Text Type: D, B5
[47816949]
Accuracy testing was performed using an in-house retained reagent pack of architect cyclosporine assay lot 50160m500 (no returns were made available from the customer site). All results met specifications indicating acceptable performance of this reagent lot. 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 architect cyclosporine assay package insert contains information to address the current customer issue. Based on the available information from the customer site and from the results of this evaluation, there is no evidence to reasonably suggest a product malfunction occurred. The issue involves one discreet patient sample and retesting resulted in a lower result indicating a possible sample integrity issue. Additionally, the result was obtained with expired precipitation reagent. Section corrected to ln: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2016-00059 |
| MDR Report Key | 5673838 |
| Date Received | 2016-05-23 |
| Date of Report | 2016-06-09 |
| Date of Event | 2016-05-02 |
| Date Mfgr Received | 2016-06-09 |
| Device Manufacturer Date | 2016-01-01 |
| Date Added to Maude | 2016-05-23 |
| 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 | 3 |
| Brand Name | ARCHITECT CYCLOSPORINE |
| Generic Name | CYCLOSPORINE |
| Product Code | MKW |
| Date Received | 2016-05-23 |
| Catalog Number | 01L75-25 |
| Lot Number | 50160M500 |
| Device Expiration Date | 2016-11-11 |
| 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 LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK ROAD ABBOTT PARK IL 600643500 US 600643500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-23 |