MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2015-03-11 for PRISM 6 CHANNEL ANALYZER 06A36-04 manufactured by Abbott Manufacturing Inc.
[5627776]
The customer observed (b)(6) combo results while using the prism reaction trays on the prism 6 channel ce analyzer. The customer indicated that a plasma sample generated the following results: (b)(6). There was no adverse impact to patient management reported. No additional patient information has been provided.
Patient Sequence No: 1, Text Type: D, B5
[12990904]
(b)(4). A follow-up report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[34460939]
Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, a review of labeling, and specificity testing on returned samples and panel members. The customer observed (b)(6) results when using abbott prism (b)(6) combo, lot 43996li00, and abbott prism reaction trays, lot 41073m500. A review of complaint data for the products did not identify elevated complaint activity. Review of the manufacturing records for both lots did not reveal any issues related to the customer's observation. A review of labeling was also performed and found adequate information on detecting and resolving the customer's issue. Clinical specificity testing was performed on the customer's three returned samples and all were non-reactive. Additionally, 104 members of a human negative population panel were tested using prism (b)(6), lot 43996li00, with prism reaction trays, lot 41073m500, and they were all non-reactive; thus there is no malfunction. Based on all available information and this complaint investigation, the assay performed as intended and no product deficiency was identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2015-00099 |
| MDR Report Key | 4591351 |
| Report Source | 01,05 |
| Date Received | 2015-03-11 |
| Date of Report | 2014-12-08 |
| Date of Event | 2014-12-06 |
| Date Mfgr Received | 2015-06-19 |
| Device Manufacturer Date | 2001-10-03 |
| Date Added to Maude | 2015-04-14 |
| 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 | 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 | 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 | PRISM 6 CHANNEL ANALYZER |
| Generic Name | AUTOMATED IMMUNOASSAY ANALYZER |
| Product Code | NHS |
| Date Received | 2015-03-11 |
| Catalog Number | 06A36-04 |
| 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 MANUFACTURING INC |
| Manufacturer Address | 1921 HURD DRIVE IRVING TX 75038 US 75038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-11 |