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 2017-02-07 for CLIN CHEM LDH 02P56-21 manufactured by Abbott Manufacturing Inc.
[66776393]
Patient id contains too many characters to fit in the patient identifier field: (b)(6) 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
[66776394]
The customer stated that an elevated ldh result of 910 u/l was generated. The sample was repeated in duplicate and results of 198 and 202 u/l were generated. There was no report of impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
[69603457]
No patient sample was available for investigation. Customer complaint data was reviewed and no adverse or non-statistical trends were identified. A review for non-conformances, pncrs, or deviations was performed for the clinical chemistry ldh reagent and none were identified. The architect system operations manual and the clinical chemistry ldh reagent package insert were reviewed and were found to adequately address the issue. In addition technical bulletin 1005-2013 rev 05 states abbott has received numerous complaints regarding incorrect patient results for multiple reagents that are not due to reagent deficiencies. Customers must follow manufacturer's instructions for both tubes and centrifuges. Serum and plasma samples, if not spun according to manufacturer's specifications, may generate inaccurate values. If a customer suspects incorrect results have been generated, ensure they have followed manufacturer's specifications for both tubes and the centrifuge. If not, they should re-run the sample after manufacturer's specifications have been followed. Normal instrument troubleshooting should also be performed. It is critical that spin times are not reduced as compensation for higher centrifuge speeds. A customer letter summarizing the tb is attached to the tb and may be sent to customers as-needed. The instrument history and maintenance logs from the customer's instrument serial number (b)(4) were reviewed. Review of the history log shows 13 occurrences of ec 3375 (aspiration error) and 22 occurrences of ec 0550 (instrument hard stops) from december 1, 2016 to january 31, 2017. Review of the maintenance log shows the customer did not perform as needed maintenance (6052) until after the discrepant result. The investigation did not identify a product deficiency.
Patient Sequence No: 1, Text Type: N, H10
[74628595]
The device evaluation was reassessed and concluded that a malfunction occurred, therefore, the device was not performing as intended at the customer site. However no systemic issue and/or product deficiency was identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2017-00030 |
| MDR Report Key | 6309382 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-02-07 |
| Date of Report | 2017-04-27 |
| Date of Event | 2017-01-16 |
| Date Mfgr Received | 2017-04-24 |
| Device Manufacturer Date | 2016-10-10 |
| Date Added to Maude | 2017-02-07 |
| 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 | CLIN CHEM LDH |
| Generic Name | LACTATE DEHYDROGENASE |
| Product Code | CFJ |
| Date Received | 2017-02-07 |
| Catalog Number | 02P56-21 |
| Lot Number | 89174UN16 |
| Device Expiration Date | 2017-08-02 |
| 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 | 2017-02-07 |