MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-05-03 for CLINICAL CHEMISTRY PHOSPHORUS 07D71-31 manufactured by Abbott Manufacturing Inc.
[74477589]
Lot/serial number was manufactured prior to udi compliance date; therefore, only a di is provided further investigation of the customer issue included a review of the complaint data, a search for similar complaints, and a review of labeling. Return material was not available. Tracking and trending did not identify an adverse. Labeling was reviewed and found to be adequate. Based on the available information no product deficiency of the clinical chemistry phosphorus assay, list number 07d71, lot 91772un16, was identified.
Patient Sequence No: 1, Text Type: N, H10
[74477590]
The customer observed falsely decreased clinical chemistry phosphorus results for five patients. The customer indicated they were generating results of <0. 7 mg/dl for each patient, the retest was within range. Initial and retest results for four of the five patients was provided as follows: on (b)(6) 2016: initial <0. 7 mg/dl, retested on (b)(6) 2016 on a second analyzer: 2. 0 mg/dl sid (b)(6) initial <0. 7, retest 1. 8 mg/dl; sid (b)(6) initial <0. 7, retest 2. 0 mg/dl; sid (b)(6) initial <0. 7, retest 2. 0 mg/dl. (customer normal patient range 2. 3 - 4. 7 mg/dl). There was no adverse impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2017-00175 |
| MDR Report Key | 6541452 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-05-03 |
| Date of Report | 2017-05-03 |
| Date of Event | 2016-08-07 |
| Date Mfgr Received | 2017-04-12 |
| Device Manufacturer Date | 2016-02-24 |
| Date Added to Maude | 2017-05-03 |
| 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 | 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 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 | CLINICAL CHEMISTRY PHOSPHORUS |
| Generic Name | PHOSPHORUS |
| Product Code | CEO |
| Date Received | 2017-05-03 |
| Catalog Number | 07D71-31 |
| Lot Number | 91772UN16 |
| Device Expiration Date | 2017-03-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2017-05-03 |