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 2017-04-05 for CLINICAL CHEMISTRY PHOSPHORUS 07D71-31 manufactured by Abbott Manufacturing Inc.
[72098759]
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
[72098760]
The customer reports discrepant clin chem phosphorus assay results generated on an architect c16000 analyzer. The following examples were provided: sid (b)(6)= 4. 1 and 12. 0 mg/dl; sid (b)(6)= 4. 1 and 14. 0 mg/dl. Controls were within specification. No suspect results were reported from the lab. There is no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[80826727]
A review of complaint tracking and trending metrics was performed and identified no adverse trends in conjunction with the complaint issue currently under evaluation. A review of the instrument logs shows 63 occurrences of (b)(4). Promptly perform the wash cuvettes procedure). Use error may have contributed to the customer's issue as these error codes indicate the instrument may have dirty cuvettes, which could affect the optical readings. The architect clin chem phosphorus assay package insert contains information to address the current customer issue. Based on the results of this evaluation and the information from the customer site, a product malfunction was identified as the device failed to meet performance specifications or otherwise perform as intended at the customer site. However, no systemic issue or product deficiency was identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2017-00091 |
| MDR Report Key | 6460883 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-04-05 |
| Date of Report | 2017-06-16 |
| Date of Event | 2017-03-17 |
| Date Mfgr Received | 2017-06-16 |
| Device Manufacturer Date | 2016-08-30 |
| Date Added to Maude | 2017-04-05 |
| 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 | 2017-04-05 |
| Catalog Number | 07D71-31 |
| Lot Number | 88137UN16 |
| Device Expiration Date | 2017-09-10 |
| 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 | 2017-04-05 |