MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2015-02-26 for PRISM 6 CHANNEL ANALYZER 06A36-04 manufactured by Abbott Manufacturing Inc.
[5512093]
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 (s/co): (b)(6) 2015: initial 2. 74 (reactive); (b)(6) 2015: retest 1. 26 (b)(6), retested 0. 31 (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
[13020742]
(b)(4). A follow-up report will be submitted when the evaluation is complete. An evaluation is in-process.
Patient Sequence No: 1, Text Type: N, H10
[34461547]
Further evaluation of the customer issue included a review of the complaint text, in-house testing, batch record review, a search for similar complaints, and a review of product labeling. Return material was not available. A clinical specificity testing protocol was executed using the reaction tray lot in question with the prism (b)(6) combo assay. Testing met the acceptance criteria and determined the products are meeting expected specificity requirements and are performing acceptably. No issues were identified from the batch record review which would indicate a product deficiency. Tracking and trending did not identify an adverse trend. Labeling was reviewed and found to be adequate. Based on the available information no product deficiency of the prism 6 channel analyzer, list number 6a36, was identified.
Patient Sequence No: 1, Text Type: N, H10
[35152566]
A second (b)(4) ag/ ab combo lot number was added to the conconitant medical products field. An evaluation is in-process.
Patient Sequence No: 1, Text Type: N, H10
[35152567]
On 03/17/2015 additional information was provided by the customer. The customer indicated that a plasma sample generated the following (b)(6) results while using the prism reaction trays on the prism 6 channel ce analyzer (s/co): 02/16/2015: (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
| Report Number | 1628664-2015-00089 |
| MDR Report Key | 4551107 |
| Report Source | 01,05 |
| Date Received | 2015-02-26 |
| Date of Report | 2015-02-06 |
| Date of Event | 2015-02-04 |
| Date Mfgr Received | 2015-06-26 |
| Device Manufacturer Date | 1996-03-04 |
| Date Added to Maude | 2015-03-03 |
| 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 | 2015-02-26 |
| Catalog Number | 06A36-04 |
| 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 MANUFACTURING INC |
| Manufacturer Address | 1921 HURD DRIVE IRVING TX 75038 US 75038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-26 |