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 2017-09-01 for CLINICAL CHEMISTRY PHOSPHORUS 7D71-22 07D71-22 manufactured by Abbott Manufacturing Inc.
[84966411]
A review of complaint tracking and trending metrics was performed and identified no adverse or non-statistical trends in conjunction with the complaint issue currently under evaluation. No non-conformances were identified associated with the customer observations. There were no returns made available from the customer site. A review of the architect c8000 analyzer instrument logs was performed and only the morning and repeat sample results could be found. There were however, 28 occurrences of error code 3375 (unable to process test, aspiration error occurred) (b)(6) 2017. Frequent occurrences of this error code or occurrences with no assignable cause may indicate inadequate centrifugation or sample preparation. The architect clin chem phosphorus assay package insert and the architect system operations manual provide information to address the current customer issue. Based on the results of this evaluation and the information from the customer site, no systemic issue or product deficiency was identified. Use error may have contributed to the customer's issue as error codes indicate pre-analytical sample handling may have contributed to this issue. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[84966412]
The customer reports that one patient (being treated for hypercalcemia and receiving calcitonin / hemofiltered / 24 hours) sample generated the following clin chem phosphorus assay results on an architect c8000 analyzer: (b)(6): 3. 87, 2. 76, 3. 27 and 2. 52 mmol/l. The sample was drawn with a heparin collection tube. An additional sample was drawn on this patient later in the day ((b)(6)) and generated results in the range of 1. 35-1. 83 mmol/l (n=13) also drawn in a heparin collection tube. The customer then ran a sample from this same patient that was drawn in a red top collection tube ((b)(6)). This sample generated results in the range of 0. 98-1. 27 mmol/l (n=10). The customer uses a normal reference range of 0. 74-1. 52 mmol/l. The patient is in recovery. No suspect results were reported from the lab. There is no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2017-00327 |
| MDR Report Key | 6839718 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-09-01 |
| Date of Report | 2017-09-01 |
| Date of Event | 2017-08-16 |
| Date Mfgr Received | 2017-08-17 |
| Device Manufacturer Date | 2016-11-01 |
| Date Added to Maude | 2017-09-01 |
| 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 | 2017-09-01 |
| Model Number | 7D71-22 |
| Catalog Number | 07D71-22 |
| Lot Number | 03267UN16 |
| Device Expiration Date | 2017-11-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-09-01 |