MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2016-11-14 for ARCHITECT CYCLOSPORINE 01L75-25 manufactured by Abbott Laboratories.
[59732235]
(b)(6). (b)(4). 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
[59732236]
The customer observed falsely decreased cyclosporine results while using the architect cyclosprorine assay. The customer provided the following data: patient 1: initial 18. 6, retests 84, 66, 243, 194, patient 2: initial 164. 4, retests 41, 45, 68, 21, 57, 29. 2, patient 3: initial 107. 4, retests 217, 60, 343, 36, 70, 21. 7, patient 4: initial 4. 8, retests 36, 185, 133, 27, 53, 94. 8, patient 5: initial 6, retests 99, 82, 25, 43, 230, 126. 9, patient 6: initial 49. 1, retests 25, 122, 265, 122, 67, 29. 6, patient 7: intial 4. 5 retests 14. 5, 39, 308, patient 8: initial 68. 2, retests 101, 263, patient 9: intiial 25. 9, retests 85, 223, 323. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
[63293225]
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, and a review of labeling. Return material was not available from the customer. Tracking and trending did not identify an adverse trend for the lot in question. Labeling was reviewed and found to be adequate. Based on the available information no product deficiency and no malfunction of the architect cyclosporine reagent, list (b)(4), lot 50164m500, was identified.
Patient Sequence No: 1, Text Type: N, H10
[75935616]
Correction to the evaluation summary previously documented. The device evaluation was reassessed and concluded that a malfunction occurred. However, no systemic issue or product deficiency was identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2016-00109 |
| MDR Report Key | 6098692 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-11-14 |
| Date of Report | 2017-05-11 |
| Date Mfgr Received | 2017-04-24 |
| Device Manufacturer Date | 2016-04-01 |
| Date Added to Maude | 2016-11-14 |
| 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 | 2016-11-14 |
| Catalog Number | 01L75-25 |
| Lot Number | 50164M500 |
| Device Expiration Date | 2017-02-04 |
| 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 | 2016-11-14 |